[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nsclc":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,182,0,25,[9,42,79,107,130,163,184,215,286,309,342,363,392,457,483,507,527,578,599,629,667,687,714,734,779],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053537","phase-2-skb264-in-combination-with-skb118-for-non-small-cell-lung-cancer-100053537",false,"NCT07697586","SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer","A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced or metastatic NSCLC\n* Without epidermal growth factor receptor (EGFR) sensitizing mutation, and anaplastic lymphoma kinase (ALK) fusion gene.\n* Provide a tumor tissue sample.\n* At least one measurable lesion as assessed by the investigator according to RECIST v1.1.\n* ECOG performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks.\n* Adequate bone marrow, liver, kidney, and coagulation function.\n* Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.\n\nExclusion Criteria:\n\n* Histologically or cytologically confirmed co-existing small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components.\n* Participants with known metastases to meninges, brainstem metastases, metastases to spinal cord and\u002For compression, or active metastases to central nervous system (CNS).\n* Uncontrolled systemic disease as judged by the investigator.\n* Presence of uncontrolled, clinically symptomatic, or requiring repeated drainage pleural effusion, pericardial effusion, or ascites.\n* Presence of other moderate to severe lung disorders.\n* History of haemorrhagic diathesis or coagulopathy and\u002For clinically significant bleeding symptoms or risks.\n* Previous or co-existing gastrointestinal diseases, surgery, and wound healing complications.\n* Active hepatitis b or hepatitis c or co-infection with HBV and HCV.\n* Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.\n* Known hypersensitivity to the study drug or any of its components.\n* Pregnant or lactating women.","ALL","18 Years","75 Years",{"count":21,"type":22},206,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is an open-label, multi-center, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with NSCLC. The study includes a dose escalation phase and an expansion phase.",[28],"NSCLC","NOT_YET_RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":22},"2026-08",{"date":37,"type":22},"2029-08",{"name":39,"class":40},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","INDUSTRY",2,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100575356","phase-1-slv-154-treatment-of-metastatic-solid-tumors-100575356","NCT06771219","SLV-154 Treatment of Metastatic Solid Tumors","A Phase 1 Dose-Escalation Study of SLV-154 in Subjects With Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Men or women (as appropriate for cancer type) of age ≥18 years.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n3. Histologically or cytologically confirmed diagnosis of solid tumor as documented in medical records with the primary history comprising one of the following:\n\n   1. SCCHN\n   2. NSCLC\n   3. SCLC\n   4. Breast cancer\n   5. Cervical cancer\n   6. Endometrial cancer\n   7. Ovarian cancer\n   8. Urothelial cancer\n   9. Sarcoma\n   10. Thyroid cancer\n4. Presence of metastatic disease that has progressed during or following previous treatment.\n5. Presence of radiographically measurable disease.\n6. Prior receipt of commercially available therapies that are indicated for the subject's cancer and have demonstrated survival benefit for that indication.\n7. Availability of tumor tissue from a fresh tumor biopsy obtained by a core needle, excisional, or incisional biopsy; or punch biopsy (for cutaneous disease); or archival tumor sample from a previous biopsy.\n8. Availability of computed tomography (CT) or magnetic resonance imaging (MRI) of chest, abdomen, and pelvis, and\u002For fluorodeoxyglucose (FDG) positron emission tomography (PET)\u002FCT (if appropriate for tumor type) (with PET from base of the skull to mid-thigh, if performed) within 35 days before study drug administration.\n9. Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥1 week before the start of study drug administration.\n10. Adequate hematological profile.\n11. Adequate coagulation profile.\n12. Adequate hepatic profile.\n13. Adequate renal function.\n14. Negative viral serology or adequate therapy for human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection.\n15. For female subjects of childbearing potential, a negative serum pregnancy test.\n16. For female subjects of childbearing potential, willingness to use a protocol-recommended method of contraception from the start of the screening period until ≥6 months after the final dose of study therapy.\n17. For male subjects who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception, willingness to use a protocol-recommended method of contraception from the start of study therapy until ≥6 months after the final dose of study therapy and to refrain from sperm donation from the start of study therapy until ≥12 months after administration of the final dose of study therapy.\n18. Willingness and ability of the subject to comply with scheduled visits, the drug administration plan, protocol-specified laboratory tests, other study procedures (including required tumor biopsy\u002Faspirations and\u002For radiographic studies), and study restrictions.\n19. Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.\n\nExclusion Criteria:\n\n1. Malignancy involving the central nervous system unless brain metastases have been previously treated with radiotherapy, have been stable for ≥4 weeks, and do not require corticosteroids.\n2. Presence of another cancer with disease manifestations or therapy that could adversely affect subject safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results.\n3. Uncontrolled ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infection) at the time of start of study therapy.\n4. Significant cardiovascular event or comorbidity.\n5. Significant screening ECG abnormalities.\n6. Pregnancy or breastfeeding.\n7. Major surgery within 4 weeks before the start of study therapy.\n8. Use of a strong inhibitor or inducer of CYP3A4 or CYP1A2.\n9. Use of a drug known to prolong the QT interval within 7 days prior to the start of study drug administration.\n10. Concurrent participation in another therapeutic or imaging clinical trial.\n11. Other conditions likely to interfere with a subject's ability to participate in the study.",{"count":50,"type":22},70,[52],"PHASE1","This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of dose levels when administered to subjects with metastatic solid tumors.",[55,28,56,57,58,59,60,61,62,63],"Squamous Cell Cancer of Head and Neck (SCCHN)","SCLC","Cervical Cancer Metastatic","Breast Cancer Metastatic","Endometrial Cancer","Ovarian Cancer","Urothelial Cancer","Sarcoma","Thyroid Cancer",[65,66,67],"metastatic solid tumors","metastatic cancer","solid tumor","RECRUITING","2026-06-29",{"date":71,"type":33},"2026-06-30",{"date":73,"type":33},"2025-05-14",{"date":75,"type":22},"2027-04",{"name":77,"class":40},"Solve Therapeutics",10,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100473302","phase-1-a-study-of-ep0031-lunbotinib-in-patients-with-advanced-ret-altered-malignancies-100473302","NCT05443126","A Study of EP0031 (Lunbotinib) in Patients With Advanced RET-altered Malignancies","A Modular, Open-label, Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0031 in Patients With Advanced RET-altered Malignancies","Inclusion Criteria:\n\nApplicable to all participants:\n\n1. Must be ≥18 years of age, with documented RET-altered NSCLC\n2. Participants should be well informed and consented about alternative treatment options including approved RET-targeted therapies\n3. ECOG performance status of 0 or 1 and life expectancy \\>3 months at screening\n4. Ability to understand and provide written informed consent and able to participate in all required evaluations and procedures\n5. Measurable disease defined by RECIST v1.1\n6. Must have locally advanced or metastatic NSCLC with RET fusion who are eligible to receive platinum-based doublet chemotherapy.\n7. First line patients: Must not have received a Selective RET inhibitor or chemotherapy. Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation\u002Fchemoradiation with or without regimens including immunotherapy, biologic therapy, investigational agents, are permitted as long as treatment was completed at least 12 months prior. Palliative radiotherapy for symptom management (eg, bone metastases) is permitted up to 2 weeks prior to treatment start.\n\nExclusion Criteria:\n\nParticipants with any of the following will not be included in the study:\n\n1. Any known major driver gene alterations other than RET.\n2. Spinal cord compression or brain metastases. Patients with stable brain metastases can be enrolled.\n3. Active infection requiring systemic antibiotic, antifungal, or antiviral medication\n4. Severe or uncontrolled medical condition or psychiatric condition\n5. Chronic glomerulonephritis or renal transplant\n6. Participants with active hepatitis B infection or active hepatitis C\n7. Participants with active HIV infection. Patients living with HIV may be eligible if they have adequate CD4+ T-cell count and no history of AIDS-defining opportunistic infections in the past 12 months\n8. Receipt of any strong inhibitor or inducer of CYP3A4\n9. Impaired hepatic or renal function, inadequate bone marrow reserve or organ function\n10. Any clinically important abnormalities in rhythm, conduction, or morphology on resting ECG or any factor that increases the risk of QTc prolongation or of arrhythmic events , or congestive heart failure Grade III-IV according to the New York Heart Association, myocardial infarction, or unstable angina within the previous 6 months\n11. Uncontrolled hypertension\n12. Corneal ulceration or untreated keratitis at screening",{"count":87,"type":22},265,[52,25],"The aim of this study is to assess the safety, side effects and effectiveness of EP0031 (Lunbotinib) in patients with advanced RET-altered non-small cell lung cancer (NSCLC) in monotherapy and in combination with standard of care (SOC) chemotherapy.",[28],[92,28,93,94,95,96,97],"selective RET-inhibitor","RET","EP0031","A400","Chemotherapy","lunbotinib",{"date":99,"type":33},"2026-07-01",{"date":101,"type":33},"2022-09-30",{"date":103,"type":22},"2028-03",{"name":105,"class":40},"Ellipses Pharma",52,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":129},"100643047","rgl-270--ici-in-advanced-nsclc-100643047","NCT07652125","RGL-270 + ICI in Advanced NSCLC","An Exploratory Study of RGL-270 in Combination With PD-1\u002FPD-L1 Inhibitors in Patients With Unresectable Locally Advanced or Recurrent\u002FMetastatic Non-Small Cell Lung Cancer","1. Subjects capable of understanding\u002Fcompliance with study procedures and voluntarily signing informed consent.\n2. Age ≥18, any gender.\n3. Histologically\u002Fcytologically confirmed NSCLC.\n\n5.ECOG performance status 0 or 1.\n\n6.Life expectancy ≥6 months.\n\n7\\. Subject must have at least one measurable tumor lesion by RECIST 1.1 criteria at baseline prior to first-line treatment.\n\nNote: Previously irradiated lesions not eligible as target lesions unless documented progression post-radiation.\n\n8\\. Subjects with asymptomatic central nervous system (CNS) metastases (excluding meningeal or cerebrospinal membrane metastases) are allowed. For symptomatic CNS metastases, the condition must be stable after local treatment and no steroid or anticonvulsant treatment is required at least 7 days before enrollment (antiepileptic drugs are allowed).\n\n9.Willing to provide sufficient fresh tumor tissue or archival specimens for genomic profiling and neoantigen analysis (fresh tissue preferred).\n\n10.Willing to provide blood samples for immunogenicity\u002Fbiomarker assessments at all timepoints. Pre-biopsy samples require no transfusion\u002Fblood products\u002FG-CSF within 10 days.\n\n11.Adequate organ function (no blood products\u002Fgrowth factors within 10 days prior to testing):\n\nHematology:\n\nANC ≥1.5×10⁹\u002FL, LYM ≥0.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL, Hb ≥90g\u002FL\n\nBiochemistry:\n\nTBIL ≤1.5×ULN, ALT\u002FAST ≤2.5×ULN, ALB ≥30g\u002FL, Scr ≤1.5×ULN\n\nCoagulation:\n\nINR ≤1.5, APTT ≤1.5×ULN\n\nCardiac:\n\nLVEF ≥50%\n\nECG:\n\nQTcF \\\u003C470 ms (Fridericia's correction: QTcF=QT\u002FRR⁰·³³)\n\n12.Women of childbearing potential (WOCBP): Negative pregnancy test within 7 days prior to treatment; non-lactating.\n\n13.Women and male subjects with fertile partners must use contraception from consent until 90 days post-last treatment (see Appendix V).\n\nReal-World Observational Cohort Addendum:\n\nExempt from tissue provision (Criterion 9) and immunogenicity blood sampling (Criterion 10). All other inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Histologically\u002Fcytologically confirmed small cell lung cancer (SCLC), mixed tumors with SCLC components, neuroendocrine tumors with large cell components, or sarcomatoid carcinoma.\n2. Actionable driver mutations (e.g., EGFR\u002FALK) where targeted therapy is accessible per investigator assessment, except for patients refusing targeted treatment.\n3. Prior radiotherapy within 5 years or history of immunotherapy\u002Fcancer vaccines (including but not limited to TILs, CAR-T, TCR-T, therapeutic cancer vaccines).\n4. Live vaccines administered ≤28 days pre-screening or planned during study\u002Fwithin 90 days post-treatment (inactivated vaccines permitted).\n5. Investigator-assessed contraindications for immunotherapy.\n6. Active autoimmune diseases (exclusion: hypothyroidism from autoimmune thyroiditis requiring hormone replacement only).\n7. Evidence of active tuberculosis within 1 year pre-screening, regardless of treatment.\n8. History of interstitial lung disease (ILD), suspected active ILD on screening CT, or idiopathic pulmonary fibrosis\u002Forganizing pneumonia (e.g., BOOP\u002Fcryptogenic OP).\n9. Severe active infection requiring IV antibiotics\u002Fantifungals\u002Fantivirals ≤28 days pre-screening or during screening.\n10. Clinically uncontrolled effusions requiring drainage ≤14 days pre-screening (pleural\u002Fperitoneal\u002Fpericardial).\n11. Hypersensitivity to study drug excipients or severe vaccine allergy history.\n12. Other malignancies within 5 years (exceptions: cured cervical CIS, basal\u002Fsquamous skin cancer, localized prostate cancer post-radical therapy, DCIS, papillary thyroid cancer).\n13. Allogeneic organ or hematopoietic stem cell transplantation.\n14. Congenital\u002Facquired immunodeficiency (e.g., DiGeorge syndrome, T-\u002FB-cell deficiencies, Wiskott-Aldrich, ataxia-telangiectasia, CVID) or HIV infection.\n15. Active hepatitis B (defined as positive hepatitis B surface antigen \\[HBsAg\\] at screening AND HBV DNA ≥500 IU\u002FmL or above the upper limit of normal \\[ULN\\] at the local institution), OR active hepatitis C (defined as positive hepatitis C antibody \\[HCV-Ab\\] at screening AND detectable HCV-RNA).\n16. Uncontrolled or significant cardiovascular disease, including:\n\n    Symptomatic congestive heart failure (NYHA Class III or IV) Myocardial infarction within 6 months prior to screening Unstable angina within 1 month prior to screening Clinically significant arrhythmias requiring therapeutic intervention Refractory hypertension despite adequate treatment (systolic BP ≥160 mmHg and\u002For diastolic BP ≥100 mmHg)\n17. Any other condition deemed by the investigator to potentially compromise trial conduct or outcome interpretation, including but not limited to:\n\n    Anticipated poor compliance with study procedures Comorbidities posing unacceptable safety risks Insufficient neoantigen burden for vaccine production (based on tumor sequencing analysis) Vaccine manufacturing failure\n18. Subjects who experienced severe irAE during the run-in treatment period resulting in permanent discontinuation of PD-1\u002FPD-L1 inhibitors.\n19. If a subject experiences comprehensive disease progression during the introduction treatment but only has clinical deterioration, or if the intracranial lesion stabilizes after local treatment and the investigator assesses that medication can continue, they are allowed to continue participating in the study.",{"count":115,"type":22},40,[117],"NA","This is a single-center, open-label, investigator-initiated clinical trial. It aims to evaluate the safety and tolerability of RGL-270 in combination with a PD-1\u002FPD-L1 inhibitor, to assess immunogenicity, preliminary efficacy, and exploratory biomarkers and to observe the safety and effectiveness of PD-1\u002FPD-L1 inhibitor monotherapy in advanced NSCLC subjects through a real-world observational cohort.",[28],"2026-06-26",{"date":71,"type":33},{"date":123,"type":33},"2025-10-25",{"date":125,"type":22},"2027-12-31",{"name":127,"class":128},"Guangdong Association of Clinical Trials","OTHER",1,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":140,"conditions":141,"keywords":147,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100623492","phase-1-study-of-rason-inhibitors-in-combination-with-ivonescimab-in-patients-with-solid-tumors-100623492","NCT07397338","Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors","A Phase 1\u002F2 Open-Label, Multicenter Study of RAS(ON) Inhibitors in Combination With Ivonescimab With or Without Other Anti-Cancer Agents in Patients With Solid Tumors","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically confirmed, locally advanced or metastatic solid tumor malignancy with documented RAS mutation in KRAS, HRAS, or NRAS.\n* Received and progressed or been intolerant to prior standard therapy (Part 1 Dose Exploration).\n* Non-squamous NSCLC without a treatable driver mutation in other oncogenes that has not received prior systemic treatment (Arms A \\& B for Part 2 Dose Expansion).\n* Solid tumor or CRC previously treated with no more than 2 prior lines of therapy for advanced disease and progressed or been intolerant to prior standard therapies (Arm C for Part 2 Dose Expansion).\n* Measurable disease per RECIST v1.1\n* Adequate organ function (bone marrow, liver, kidney, coagulation, endocrine).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Head and neck squamous cell carcinoma.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 4 weeks prior to receiving study drug(s).\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.\n* Other inclusion\u002Fexclusion criteria may apply.",{"count":138,"type":22},370,[52,25],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RAS(ON) inhibitors in combination with ivonescimab in adults with advanced or metastatic solid tumors with a RAS mutation.",[142,143,144,28,145,146],"Advanced Solid Tumors","Metastatic Solid Tumors","Non-small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","CRC",[142,143,148,28,149,146,150,151,152,153,154],"Non-small Cell Lung Cancer","Colorectal Cancer","RAS","NRAS","KRAS","HRAS","RAS Mutation",{"date":69,"type":33},{"date":157,"type":33},"2026-01-30",{"date":159,"type":22},"2029-05",{"name":161,"class":40},"Revolution Medicines, Inc.",6,{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":23,"phases":172,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":183},"100548526","phase-3-pembrolizumab-with-or-without-maintenance-sacituzumab-tirumotecan-sac-tmt-mk-2870-in-metastatic-squamous-non-small-cell-lung-cancer-nsclc-mk-2870-023-100548526","NCT06422143","Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]","Phase 3 Study of Pembrolizumab in Combination With Carboplatin\u002FTaxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) \\[Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8\\]\n* Measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator\u002Fradiology\n* Has life expectancy ≥3 months\n* Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to allocation\n* Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg)-positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible)\n* Has adequate organ function\n* For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by BICR using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12 or most recent scan before randomization\n* For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit\n* For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade ≤2 fatigue, Grade ≤2 peripheral neuropathy, and Grade ≤2 endocrine-related AEs requiring treatment or hormone replacement) have recovered\n* For Maintenance only (prior to randomization): has not experienced a pneumonitis\u002Finterstitial lung disease (ILD) event during the study-specified induction\n\nExclusion Criteria:\n\n* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements\n* History of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>480 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention\n* HIV-infected participants who have been newly diagnosed or with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and\u002For radiation as a part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC\n* Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T lymphocyte-associated protein 4, OX-40, CD137). Note: Prior treatment with an anti-PD-1 or anti-PD-L1 agent for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC\n* Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antidrug conjugate (ADC)\n* Received radiation therapy to the lung that is \\>30 Gray within 6 months of start of study intervention\n* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Participants who have not adequately recovered from major surgery or have ongoing surgical complications\n* Received prior treatment with a topoisomerase I inhibitor-containing ADC\n* Is currently receiving a strong inducer\u002Finhibitor of CYP3A4 that cannot be discontinued for the duration of the study (the required washout period before starting sac-TMT is 2 weeks)\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Has known central nervous system (CNS) metastases\u002Fcarcinomatous meningitis\n* Severe hypersensitivity (≥Grade 3) to study intervention and\u002For any of its excipients or to another biologic therapy\n* Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapy \\[eg, thyroxine, insulin, or physiologic corticosteroid\\] is allowed)\n* Has a history of (noninfectious)pneumonitis\u002FILD that required steroids, has current pneumonitis\u002FILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening\n* Active infection requiring systemic therapy\n* History of allogeneic tissue\u002Fsolid organ transplant",{"count":171,"type":22},851,[173],"PHASE3","This is a phase 3 study of pembrolizumab in combination with carboplatin\u002Ftaxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).",[148,28],{"date":69,"type":33},{"date":178,"type":33},"2024-06-10",{"date":180,"type":22},"2031-02-12",{"name":182,"class":40},"Merck Sharp & Dohme LLC",212,{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":201,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},"100583857","phase-3-study-of-daraxonrasib-rmc-6236-in-patients-with-ras-mutated-nsclc-rasolve-301-100583857","NCT06881784","Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)","RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 Versus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC","RASolve 301","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Pathologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.\n* Measurable disease per RECIST v1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* One to two prior lines of therapy including an anti-PD-1\u002Fanti-PD(L)-1 agent and platinum-based chemotherapy.\n* Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior therapy with direct RAS-targeted therapy or docetaxel.\n* Untreated central nervous system (CNS) metastases.\n* Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function).\n* Ongoing anticancer therapy.\n* Pregnant or breastfeeding.",{"count":193,"type":22},590,[173],"The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.",[197,198,28,199,200],"NSCLC (Non-small Cell Lung Cancer)","Non-Small Cell Lung Cancer","NSCLC (Non-small Cell Lung Carcinoma)","NSCLC (Advanced Non-small Cell Lung Cancer)",[28,198,202,150,152,153,151,203,204,205],"Lung Cancer","RAS Q61 Mutation","RAS G12 Mutation","RAS G13 Mutation","2026-06-24",{"date":208,"type":33},"2026-06-25",{"date":210,"type":33},"2025-05-06",{"date":212,"type":22},"2030-12-01",{"name":161,"class":40},151,{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":17,"minAge":222,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":225,"briefSummary":226,"conditions":227,"keywords":250,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":283,"locationsCount":285},"100407463","phase-1-the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":224,"type":22},300,[52,25],"The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[228,229,230,231,202,60,59,232,149,233,234,235,236,237,238,239,240,28,197,56,241,242,243,244,198,245,246,247,248,249],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Prostate Cancer","Breast Cancer","Other Cancer","Locally Advanced","Head and Neck Cancer","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt",{"date":120,"type":33},{"date":281,"type":33},"2020-10-29",{"date":125,"type":22},{"name":284,"class":40},"PMV Pharmaceuticals, Inc",77,{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":293,"targetDuration":4,"studyType":23,"phases":295,"briefSummary":296,"conditions":297,"keywords":298,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":129},"100643885","phase-2-skb264-plus-goleirex-in-advanced-kras-g12c-mutant-nsclc-a-phase-ii-study-100643885","NCT07670013","SKB264 Plus Goleirex in Advanced KRAS G12C-Mutant NSCLC: A Phase II Study","A Multicenter, Single-Arm, Phase II (Simon Two-Stage) Study of Lucankizumab (SKB264) Plus Goleirex (KRAS G12C Inhibitor) as First-Line Treatment for KRAS G12C-Mutated Advanced NSCLC","Inclusion Criteria:\n\n* Voluntarily participate in the study and sign the informed consent form (ICF).\n* Male or female subjects aged ≥18 years and ≤75 years at the time of signing the ICF.\n* Expected survival time of ≥3 months.\n* Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) with unresectable locally advanced stage (Stage ⅢB\u002FⅢC), metastatic or recurrent stage (Stage Ⅳ) that is not eligible for radical concurrent chemoradiotherapy, in accordance with the 8th edition of the TNM --Staging System for Lung Cancer by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC).\n\nConfirmed KRAS G12C mutation-positive by a qualified laboratory (CAP\u002FCLIA or nationally accredited) using next-generation sequencing (NGS) or an equivalent method; positivity in either tissue samples or plasma circulating tumor DNA (ctDNA) is acceptable. If plasma testing is negative and tissue testing is feasible, supplementary tissue testing is recommended.\n\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1.\n* Definition for first-line systemic therapy of advanced disease: No prior systemic anti-tumor therapy for metastatic\u002Fadvanced disease. For subjects who previously received radical post-surgical therapy, chemoradiotherapy or immunotherapy alone, enrollment is permitted only if the interval from the last dose to disease recurrence is ≥6 months.\n* Presence of at least one measurable lesion in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; measurable lesions within a prior radiotherapy field or after local treatment may be selected as target lesions if disease progression is documented.\n* Sufficient organ and bone marrow function, including the following:\n\nAdequate hematopoietic function: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, platelet count ≥100×10⁹\u002FL, hemoglobin ≥9 g\u002FdL. No blood transfusion or treatment with granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), erythropoietin (EPO) or other similar agents is allowed within 14 days prior to blood routine testing.\n\n* Adequate liver function: Total bilirubin (TBIL) \\\u003C1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C2.5×ULN; for subjects with Gilbert's syndrome, TBIL \\\u003C2×ULN is acceptable; for subjects with liver metastases from tumor, AST and ALT \\\u003C5.0×ULN is required; for subjects with extrahepatic obstruction confirmed by direct bilirubin (DBIL) testing, TBIL \\\u003C3.0×ULN is permitted.\n* Adequate renal function: Serum creatinine (Cr) ≤1.5×ULN, or if Cr \\>1.5×ULN, creatinine clearance (CrCl) ≥60 mL\u002Fmin calculated by the Cockcroft-Gault formula.\n* Adequate coagulation function: Prothrombin time (PT)\u002Factivated partial thromboplastin time (APTT) \\\u003C1.5×ULN, and international normalized ratio (INR) \\\u003C1.5 or within the target range for anticoagulant therapy.\n\nSerum magnesium level within the normal range.\n\n* Toxic effects from prior anti-tumor therapy must have recovered to baseline levels (excluding residual alopecia) or grade ≤1 at enrollment (grade ≤2 neurotoxicity is acceptable). For immune-related adverse events (irAEs) involving the endocrine system caused by prior immunotherapy (e.g., immune-related hypothyroidism), subjects with well-controlled symptoms under stable-dose hormone replacement therapy or physiological-dose corticosteroid therapy may be enrolled if the investigator assesses that the treatment does not interfere with the administration of study drugs and safety evaluation.\n* Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must adopt effective contraceptive measures from the time of signing the ICF until 6 months after the last dose of study drug. Female subjects of childbearing potential must have a negative blood pregnancy test result within 7 days (inclusive) prior to the first dose of study drug. If a urine pregnancy test result is inconclusive, a blood pregnancy test is required.\n* The investigator judges that the subject is capable of effective communication, complying with scheduled follow-up visits and completing the study in accordance with the protocol requirements.\n\nExclusion Criteria:\n\n* Prior treatment with a KRAS G12C inhibitor or TROP2-ADC; any prior systemic anti-tumor therapy (chemotherapy, immunotherapy, targeted therapy, etc.) for advanced non-small cell lung cancer (NSCLC).\n* Positive for other clinically approved first-line targetable oncogenic drivers: classic sensitizing EGFR mutations (19del\u002FL858R), ALK\u002FROS1\u002FRET\u002FNTRK fusions, BRAF V600E mutation, MET exon 14 skipping mutation, and other mutations for which guideline-recommended approved first-line targeted therapies are available (to avoid conflict with current standard of care); concurrent mutations such as KRAS combined with STK11\u002FKEAP1 are not exclusion criteria.\n* Histologically or cytologically confirmed mixed NSCLC with small cell carcinoma components or predominantly squamous cell carcinoma components.\n* Significant cardiovascular and cerebrovascular diseases, including:\n\nA confirmed major cardiovascular adverse event within 6 months, such as myocardial infarction, angina pectoris, heart failure, severe arrhythmia, or receipt of angioplasty, vascular stenting, coronary artery bypass grafting, or other similar procedures; -Clinically significant prolonged QT\u002FQTcF interval on electrocardiogram (QTcF \\>470 ms in females or QTcF \\>450 ms in males); A confirmed major cerebrovascular adverse event within 3 months, such as intracerebral hemorrhage or cerebral infarction.\n\nUncontrolled central nervous system (CNS) disease: active CNS metastases requiring urgent local therapy; meningeal carcinomatosis.\n\n-Interstitial lung disease (ILD)\u002Fdrug-induced pneumonitis: active ILD\u002Fpneumonitis or a history of ILD\u002Fpneumonitis requiring systemic corticosteroid therapy; baseline chest imaging showing active ILD-like changes.",{"count":294,"type":22},43,[25],"This is a multicenter, single-arm, phase II (Simon two-stage) prospective interventional clinical study. The primary objective is to evaluate the efficacy and safety of lucankizumab (SKB264) in combination with golelixir (a KRAS G12C inhibitor) as first-line treatment in patients with KRAS G12C-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Specifically, the primary endpoint is the objective response rate (ORR) assessed by investigators per RECIST 1.1 to verify the core antitumor activity of the combination regimen. Secondary objectives include comprehensive evaluation of overall efficacy via disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), and overall survival (OS). Safety will be monitored in accordance with NCI CTCAE 5.0, including the incidence and severity of adverse events (AEs) and serious adverse events (SAEs), to characterize the safety profile of the combination and the feasibility of dose modifications. This study aims to provide scientific evidence for the use of this combination regimen as first-line therapy for KRAS G12C-mutated advanced NSCLC and to explore a more optimal treatment option for this patient population.",[28],[299,300],"SBK264","Goleirex","2026-06-22",{"date":208,"type":33},{"date":304,"type":33},"2026-04-01",{"date":306,"type":22},"2028-06",{"name":308,"class":128},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":23,"phases":317,"briefSummary":319,"conditions":320,"keywords":324,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":129},"100644477","early-phase-1-imaging-study-of-a-trop2-binder-in-metastatic-uc-hr-and-her2--breast-cancer-tnbc-and-nsclc-100644477","NCT07671092","Imaging Study of a TROP2 Binder in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC","A Phase 0 Imaging Study to Assess the Feasibility, Biodistribution, and Dosimetry of a Trophoblast Cell Surface Antigen 2 (TROP2) Binder in Metastatic Urothelial Cancer (UC), Hormone Receptor-Positive (HR+) and Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Breast Cancer, Triple-Negative Breast Cancer (TNBC), and Non-Small-Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n* Are at least 18 years old at the time of signing the informed consent form (ICF)\n* Have biopsy proven metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC\n\nExclusion Criteria:\n\n* TROP2-targeting antibody-drug conjugates (ADCs) such as sacituzumab govitecan or datopotamab deruxtecan, should be discontinued at least 90 days prior to administration of RYZ211 and RYZ212\n* For Women of Childbearing Potential: Are pregnant or breastfeeding\n\nNote: Additional criteria may apply and will be assessed by the study site",{"count":115,"type":22},[318],"EARLY_PHASE1","This imaging study aims to assess the feasibility, biodistribution, and dosimetry of a TROP2 binder in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.",[321,233,322,323,28],"Metastatic Urothelial Carcinoma","TNBC - Triple-Negative Breast Cancer","Hormone Receptor Positive HER-2 Negative Breast Cancer",[325,326,233,327,242,328,243,329,330,331,332,333,334],"HR+","HER2-","Non Small Cell Lung Cancer","Trop2","RayzeBio","Rayze","BMS","Bristol Myers Squibb","RPT","Imaging Agent",{"date":120,"type":33},{"date":337,"type":22},"2026-06",{"date":339,"type":22},"2027-10",{"name":341,"class":40},"RayzeBio, Inc.",{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":23,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":4},"100644429","phase-2-the-efficacy-and-safety-of-trastuzumab-deruxtecan-in-advanced-or-metastatic-nsclc-with-her2-over-expression-100644429","NCT07662473","The Efficacy and Safety of Trastuzumab Deruxtecan in Advanced or Metastatic NSCLC With HER2 Over Expression","The Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) in Advanced or Metastatic NSCLC With Human Epidermal Growth Factor Receptor2(HER2) Overexpression(OE)：A Single-arm, Multicenter, Prospective Study","Inclusion Criteria:\n\n1. Male and female participants must be at least 18 years of age at the time of signing the ICF.\n2. Histologically documented Stage III locally advanced and unresectable non-squamous NSCLC not amenable to curative surgery or radiation and\u002For Stage IV NSCLC.\n3. Participants must have HER2 overexpression (IHC 3+).\n4. progressed following at least one or two prior systemic treatment.\n5. Prior anti-HER2 are eligible except for HER2 ADC.\n6. At least 1 measurable lesion by the investigator based on RECIST 1.1.\n7. LVEF ≥ 50% within 28 days before enrollment.\n8. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1.\n9. Adequate organ and bone marrow function within 14 days before enrolment. All parameters must be the most recent results available.\n10. Adequate treatment washout period before enrolment.\n11. Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner.\n\nExclusion Criteria:\n\n1. Has spinal cord compression or clinically active central nervous system metastases.\n2. Corrected QT interval (QTcF) prolongation to \\> 470 msec (females) or \\>450 msec (males) based on average of the screening triplicate12-lead ECG.\n3. History of (non-infectious) ILD \u002F pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n4. Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals\n5. Active primary immunodeficiency, known uncontrolled active human immunodeficiency virus (HIV) infection or active hepatitis B (hepatitis B virus surface antigen or hepatitis B virus core antibody positive, at screening) or C infection.\n6. Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan.\n7. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline.\n8. Known allergy or hypersensitivity to study treatment or any of the study drug excipients\n9. History of severe hypersensitivity reactions to other monoclonal antibodies.\n10. Pregnant or breastfeeding female participants, or participants who are planning to become pregnant.\n11. A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).\n12. Any other clinically significant medical conditions, that may, in the opinion of the investigator, interfere with the participant's participation in the clinical study or evaluation of the clinical study results.",{"count":350,"type":22},30,[25],"This is a single arm, multicenter and prospective study to evaluate the efficacy and safety of T-DXd for the treatment in locally advanced, unresectable, or metastatic participants with selected HER2 positive (IHC 3+) NSCLC which are not eligible for curative therapy",[28],"2026-06-19",{"date":356,"type":33},"2026-06-23",{"date":358,"type":22},"2026-07-29",{"date":360,"type":22},"2028-06-30",{"name":362,"class":128},"Hunan Province Tumor Hospital",{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":23,"phases":372,"briefSummary":373,"conditions":374,"keywords":381,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":129},"100371266","phase-2-anti-pd-1-mab-plus-metabolic-modulator-in-solid-tumor-malignancies-100371266","NCT04114136","Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies","A Phase II Clinical Trial of Anti-PD-1 mAb Therapy Alone or With Metabolic Modulators to Reverse Tumor Hypoxia and Immune Dysfunction in Solid Tumor Malignancies","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction\u002FGastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy.\n2. Accessible tumor for pretreatment (baseline) and post treatment biopsy. Tumor must be accessible for core or surgical biopsy (excisional\u002Fincisional), FNA is not adequate\n3. Age ≥ 18 years\n4. Have at least one measurable area of disease (Target Lesion) based on RECIST 1.1.\n5. ECOG performance status 0-2\n6. Patients must have normal organ and marrow function as defined below:\n\n   absolute neutrophil count ≥1,500\u002FmcL platelets ≥100,000\u002FmcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional ULN Creatinine clearance ≥40 mL\u002Fmin\u002F1.73 m2\n7. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n8. Female subjects of childbearing potential should be willing to use one methods of birth control or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n9. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n10. Ability to understand and the willingness to sign a written informed consent document\n11. If known to have prior brain metastases, must not have evidence of active (enlarging and\u002For symptomatic lesions) brain disease on MRI\u002FCT evaluation.\n12. A type II DM patient who does not currently require prescription medication for diabetes treatment and has not received metformin, insulin, sulfonylureas or thiazolidinediones within 60 days of the start of study treatment can be enrolled on the study.\n\nExclusion Criteria:\n\n1. Treatment with prior anti-PD-1 or anti-PD-L1 mAb therapy\n2. Patients with type I DM or any patient who has received metformin, insulin, sulfonylureas, or thiazolidinediones within 60 days of start of study treatment for any reason.\n3. Pregnancy or breastfeeding. Women of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study must be informed of the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.\n4. All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study.\n5. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic therapy or resolved childhood asthma\u002Fatopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.\n6. History of uncontrolled cardiac disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within prior 6 months)\n7. Symptomatic heart failure or New York Heart Association Class III or IV heart failure\n8. Psychiatric illness or other social issues limiting compliance\n9. Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis.\n10. Treatment with a non-approved or investigational drug within 14 days prior to Day 1 of study treatment.\n11. Prior malignancy within 2 years with the exception of adequately treated basal cell or squamous cell skin cancer, carcinoma of the cervix or prostate cancer.\n12. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n13. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies). Per Medical History Review\n14. Hypersensitivity to metformin, rosiglitazone, pembrolizumab or nivolumab\n15. Unable to take in pills either orally or via feeding tube\n16. History of acidosis of any type or habitual intake of 5 or more alcoholic beverages a day.\n17. Patients that require active treatment with Rifampin or Gemfibrozil for other medical conditions.",{"count":371,"type":22},72,[25],"Patients with histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction\u002FGastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy, who meet eligibility criteria will undergo a biopsy (core or excisional\u002Fincisional; FNA not adequate) for baseline tissue. Patients will then be randomized to one of 3 arms: Anti-PD-1 mAb plus Metformin 500mg po BID, Anti-PD-1 mAb alone, Anti-PD-1 mAb plus Rosiglitazone 4mg po qdaily. Five weeks (+\u002F- 7 days) after initiation of therapy a patient will undergo a repeat biopsy (core or excisional\u002Fincisional; FNA not adequate) for correlative analysis. The patient will then continue on study therapy for up to 2 years, or until progression of disease or unacceptable toxicity, whichever occurs first. RECIST 1.1 with modifications, to allow for continued therapy until progressive disease is confirmed if the patient is clinically stable, will be used in the trial.",[375,28,376,61,377,378,379,380],"Melanoma","Hepatocellular Carcinoma","Gastric Adenocarcinoma","HNSCC","Esophageal Adenocarcinoma","Microsatellite Instability-High Solid Malignant Tumor",[382,383],"Anti-PD-1 monoclonal antibody (mAb)","tumor infiltrating lymphocytes (TIL)","2026-06-18",{"date":356,"type":33},{"date":387,"type":33},"2020-09-14",{"date":389,"type":22},"2032-04-30",{"name":391,"class":128},"Dan Zandberg",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":23,"phases":401,"briefSummary":402,"conditions":403,"keywords":432,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":454,"locationsCount":456},"100499720","phase-1-phase-12-trial-of-s241656-in-selected-rasmapk-mutation--positive-malignancies-100499720","NCT05786924","Phase 1\u002F2 Trial of S241656 in Selected RAS\u002FMAPK Mutation- Positive Malignancies","A Phase 1\u002F2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With KRAS, BRAF and Other Selected RAS\u002FMAPK Mutation-Positive Malignancies","Key Inclusion Criteria:\n\n* Life expectancy of ≥ 12 weeks in the opinion of the investigator.\n* Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations or alterations.\n* Adequate bone marrow and organ function.\n* Recovered from toxicity to prior anti-cancer therapy.\n\nPart 1 Dose Escalation cohort ONLY:\n\n* Part 1A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C, HRAS, NRAS, BRAF or CRAF (RAF1) mutations or alterations\n* Part 1B: Advanced\u002Fmetastatic GI tumors (e.g., PDAC, CRC, and BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1C: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1D: Colorectal adenocarcinoma with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1E: Other advanced\u002Fmetastatic non-GI, non-NSCLC solid tumors with KRAS, HRAS, NRAS, BRAF, CRAF (RAF1) mutations or alterations\n\nPart 2 Dose Optimization and Expansion cohorts ONLY:\n\n* Part 2A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations and\u002For BRAF mutations\n* Part 2A1: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations\n* Part 2A2: Advanced\u002Fmetastatic NSCLC with BRAF mutations\n* Part 2A3: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C or BRAF mutations or alterations and active CNS metastatic disease\n* Part 2A4: Advanced\u002Fmetastatic NSCLC with a KRAS G12C mutation\n* Part 2B1: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B2: Advanced\u002Fmetastatic CRC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B3: Advanced\u002Fmetastatic BTC (adenocarcinoma) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n\nKey Exclusion Criteria:\n\n* Cancer that has a known MEK1\u002F2 mutation.\n* Known allergy\u002Fhypersensitivity to excipients of S241656 or to any of the registered IMPs administered in combination.\n* Any contra-indication, to use of any of the combination chemotherapy or anti-EGFR therapy partners administered as part of this trial.\n* Major surgery within 4 weeks of study entry or planned during study.\n* Ongoing anticancer therapy.\n* Ongoing radiation therapy.\n* Uncontrolled or active clinically relevant bacterial, fungal, or specific viral infection requiring systemic therapy.\n* Clinically significant cardiovascular disease.\n* Symptomatic spinal cord compression.\n* Evidence of active malignancy (other than study-specific malignancies) requiring systemic therapy within the next 2 years.\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.\n* Females who are pregnant or breastfeeding.\n* Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.\n* Prior use of experimental agents that target the KRAS\u002FBRAF\u002FMEK\u002FERK pathway.",{"count":400,"type":22},554,[52,25],"BDTX-4933-101 is a first-in-human, open-label, Phase 1\u002F2 dose escalation, dose optimization and expansion study designed to evaluate the safety and tolerability of S241656 as monotherapy and in combination with other anti-cancer therapies in participants with selected advanced malignancies. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced\u002Fmetastatic non-small cell lung cancer (NSCLC), Gastrointestinal (GI) cancers, and other solid tumors harboring KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (Rapidly Accelerated Fibrosarcoma (RAF1)) mutations or alterations. A dose optimization part in adults with NSCLC may follow the dose escalation phase if the sponsor, in consultation with the safety review committee, decides it is necessary to further characterize the optimal dose. However, the study may also proceed directly to the expansion phase. The study population for the Dose Expansion part of the study comprises adults with advanced\u002Fmetastatic NSCLC with KRAS and\u002For BRAF mutations, and with Pancreatic Ductal AdenoCarcinoma (PDAC), ColoRectal Cancer (CRC), and Biliary Tract Cancer (BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations and alterations. All patients will self-administer S241656 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.",[148,404,405,406,407,408,409,410,411,412,413,414,28,415,416,417,418,419,420,63,421,149,422,423,424,425,426,427,428,429,430,431],"Histiocytic Neoplasm","Histiocytosis","BRAF Gene Mutation","BRAF V600E","BRAF V600 Mutation","BRAF Mutation-Related Tumors","BRAF","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Lung Cancer","Recurrent Lung Cancer","Recurrent Lung Non-Small Cell Carcinoma","Solid Tumor","Solid Carcinoma","KRAS G12D","KRAS G12V","KRAS Mutation-Related Tumors","NRAS Gene Mutation","Thyroid Carcinoma","Colorectal Carcinoma","Recurrent Histiocytic and Dendritic Cell Neoplasm","Brain Metastases","Recurrent NSCLC","KRAS G13C","Acquired Resistance to KRAS G12C Inhibitor","KRAS G12A","KRAS G12F","KRAS G12R","KRAS G13D",[433,434,435,152,436,437,254,438,439,440,441,150,442,443,444,445,446,151,447],"BRAF Class I","BRAF Class II","BRAF Class III","Intolerant histiocytic neoplasm","BDTX-4933","dose escalation","dose expansion","MAPK","mitogen-activated protein kinase","RAF","Upstream oncogenic alterations","RAF inhibitor","intracranial disease","CRAF","RAF fusions","2026-06-16",{"date":450,"type":33},"2026-06-17",{"date":452,"type":33},"2023-04-18",{"date":306,"type":22},{"name":455,"class":128},"Institut de Recherches Internationales Servier",27,{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":23,"phases":466,"briefSummary":467,"conditions":468,"keywords":469,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":115},"100368421","phase-1-a-study-of-regn5093-in-adult-patients-with-mesenchymal-epithelial-transition-factor-met-altered-advanced-non-small-cell-lung-cancer-100368421","NCT04077099","A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer","A Phase 1\u002F2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer","Key Inclusion Criteria:\n\n1. Histologically confirmed advanced NSCLC that is unresectable or metastatic as described in the protocol\n2. Willing to provide tumor tissue as described in the protocol\n3. Documented presence of MET alteration as described in the protocol.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n5. Adequate organ and bone marrow function as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Has received treatment with an approved systemic therapy or has participated in any study of an investigational agent or investigational device within 2 weeks as described in the protocol\n2. Has not yet recovered from any acute toxicities resulting from prior therapy with certain exceptions as described in the protocol\n3. Has received radiation therapy or major surgery within 14 days as described in the protocol\n4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease or spinal cord compression as defined in the protocol\n5. Uncontrolled infection as described in the protocol\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria apply",{"count":465,"type":22},231,[52,25],"This study will evaluate REGN5093 for the treatment of Non-Small Cell Lung Cancer (NSCLC) with MET alteration. The main purpose of this study is to determine the safety, tolerability, and effectiveness of REGN5093.\n\nThe study has two phases. The main goal of Phase 1 is to determine a safe dose(s) of REGN5093. The main goal of phase 2 of the study is to use the REGN5093 drug dose(s) found in Phase 1 to see how well REGN5093 works to shrink tumors.\n\nThe study is looking at several other research questions, including:\n\n* Side effects that may be experienced by people taking REGN5093\n* How REGN5093 works in the body\n* How much REGN5093 is present in the blood\n* To see if REGN5093 works to reduce or delay the progression of cancer\n* How long it takes REGN5093 to work in the body",[28],[470,471,472,473,474,475],"MET (mesenchymal-epithelial transition factor)","HGF (Hepatocyte Growth Factor)","NSCLC (non-small cell lung cancer)","MET-altered advanced","Unresectable","Metastatic disease",{"date":450,"type":33},{"date":478,"type":33},"2020-01-07",{"date":480,"type":22},"2032-04-22",{"name":482,"class":40},"Regeneron Pharmaceuticals",{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":490,"targetDuration":4,"studyType":23,"phases":492,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":129},"100599800","phase-2-tislelizumab-combined-with-anlotinib-and-nab-paclitaxel-in-iii-resectable-non-small-cell-lung-cancer--a-prospective-single-arm-phase-ii-study-100599800","NCT07089199","Tislelizumab Combined With Anlotinib and Nab-paclitaxel in III Resectable Non-small Cell Lung Cancer : A Prospective, Single-Arm, Phase II Study","TitAN","Inclusion Criteria:\n\n1. Age 18-75 years old, gender is not limited;\n2. Histologically confirmed Stage III non-small cell lung cancer (AJCC Stage 8th edition)\n3. The tumor is resectable after assessment by the attending surgeon\n4. EGFR\u002FALK mutation negative or unknown (unknown only for squamous non-small cell lung cancer)\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n6. No previous treatment received\n7. At least 1 measurable lesion as defined by RECIST v1.1\n8. Be able to provide the Informed Consent Form (ICF), and be able to understand and agree to abide by the research requirements and assessment schedule\n9. Good organ function; • Patients have not received blood transfusion or growth factor support therapy ≤ 14 days prior to sample collection during the screening period and: Absolute neutral cell count (ANC) ≥1.5 x 109\u002FL Platelet ≥100 x 109\u002FL Hemoglobin ≥90 g\u002FL • Calculated creatinine clearance (CrCl) (Cockcroft-Gault formula) creatinine clearance ≥ 45 mL\u002Fmin Serum total bilirubin ≤1.5 × upper limit of normal (ULN) (patients with Gilbert\\'s syndrome must have total bilirubin \\< 3 × ULN) AST and ALT≤ 2.5 x ULN Patients who did not receive anticoagulant therapy: International standardized ratio or activated partial thromboplastin time ≤ 1.5 × ULN\n10. Women of childbearing age must take a serum pregnancy test within 3 days before the first medication, and the result is negative. Female subjects of reproductive age and male subjects whose partners are women of reproductive age must agree to use highly effective methods of contraception during the study period and for 120 days after the last dose of the study drug\n\nExclusion Criteria:\n\n1. A history of received treatment for current lung cancer, including radiotherapy and all systemic antitumor agents, including chemotherapy, immunotherapy, targeted therapy or antiangiogenic therapy.\n2. Patients with known EGFR gene mutation, ALK rearrangement, ROS-1 fusion, RET fusion, HER-2 mutation, MET mutation, but if patients with squamous non-small cell lung cancer, the EGFR mutation status and ALK mutation status are unknown, it is not required to conduct tests during screening\n3. There are multiple factors influencing patients taking oral medication (such as inability to swallow, chronic diarrhea, intestinal obstruction)\n4. Allergy to any study drug (Tislelizumab, Anlotinib, albumin-bound Paclitaxel) or excipients.\n5. Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor invasion of important blood vessels during treatment is likely to cause fatal bleeding.\n6. Clinically significant hemoptysis (more than 50 ml per day) within 3 months before the study, or clinically significant bleeding symptoms or obvious bleeding tendency (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above baseline, or suffering from vasculitis, etc.).\n7. Vaccination with attenuated live vaccines within 4 weeks before the first dose or planned vaccination during the study period.\n8. Patients who are expected to be unable to tolerate surgery, such as those with cardiopulmonary insufficiency.\n9. Occurrence of or concurrent other malignancies within the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\\].\n10. Patients with active viral hepatitis requiring treatment as determined by the investigator.\n11. Active autoimmune diseases requiring systemic treatment, or long-term use of high doses of steroids or other immunomodulators, which the investigator assesses as affecting the study treatment.\n12. Unhealed surgical incisions before the start of study treatment (small biopsy incisions can be included).\n13. Active hepatitis B\u002FC infection and human immunodeficiency virus (HIV) infection.\n14. Arterial or venous thrombotic events within 6 months (such as cerebrovascular accident, deep vein thrombosis, pulmonary embolism, etc.) or severe cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, uncontrolled arrhythmias; heart failure above grade III-IV according to NYHA standards, or left ventricular ejection fraction (LVEF) \\\u003C 50% as indicated by echocardiography.\n15. Interstitial lung disease, uncontrolled systemic medical history, including diabetes, hypertension, acute lung disease, etc.\n16. Active bleeding or coagulation dysfunction (INR \\> 2.0, PT \\> 16s), bleeding tendency or receiving thrombolytic, anticoagulant, antiplatelet therapy; any major surgery requiring general anesthesia within ≤ 28 days before the first dose.\n17. Underlying medical conditions or alcohol\u002Fdrug abuse that are unfavorable for the administration of study drugs, may affect the interpretation of results, or pose a high risk of treatment complications.",{"count":491,"type":22},34,[25],"This study is a single-arm prospective clinical trial. The primary objective of the study is to explore the efficacy and safety of preoperative neoadjuvant therapy with Tislelizumab combined with Anlotinib and Nab-Paclitaxel in resectable stage III non-small cell lung cancer.Finally, it provides new evidence-based medical evidence for the perioperative treatment of non-small cell lung cancer.",[28,495,496,497],"Tislelizumab","Anlotinib","Nab-paclitaxel","2026-06-11",{"date":500,"type":33},"2026-06-15",{"date":502,"type":33},"2025-07-25",{"date":504,"type":22},"2028-07-10",{"name":506,"class":128},"Qilu Hospital of Shandong University",{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":514,"targetDuration":4,"studyType":23,"phases":516,"briefSummary":517,"conditions":518,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":523,"leadSponsor":525,"locationsCount":129},"100620520","phase-2-toripalimab-combined-with-platinum-based-chemotherapy-with-or-without-h1-receptor-antagonist-in-the-perioperative-treatment-of-resectable-non-small-cell-lung-cancer-100620520","NCT07358689","Toripalimab Combined With Platinum-based Chemotherapy With or Without H1 Receptor Antagonist in the Perioperative Treatment of Resectable Non-small Cell Lung Cancer","Toripalimab Combined With Platinum-based Chemotherapy With or Without H1 Receptor Antagonist (Diphenhydramine) in the Perioperative Treatment of Resectable Non-small Cell Lung Cancer: A Single-center, Randomized Controlled Phase II Clinical Trial","Inclusion Criteria:\n\n* Voluntarily participate in this study, sign the informed consent form, have good compliance, and are willing to cooperate with follow-up visits;\n* Aged 18-75 years, regardless of gender;\n* ECOG performance status score of 0-1;\n* Expected survival time ≥ 3 months;\n* \\- Pathologically\u002Fradiologically confirmed stage II-III NSCLC (AJCC 9th Edition). For adenocarcinoma\u002Fadenosquamous carcinoma, EGFR wild-type and ALK fusion-negative required before enrollment;\n* No prior systemic anti-tumor therapy;\n* At least one measurable lesion per RECIST 1.1. Previously irradiated lesions are measurable if progression is confirmed;\n* Adequate organ function, as evidenced by meeting the following laboratory parameters:\n\n  1. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL without administration of granulocyte colony-stimulating factor within the past 14 days;\n  2. Platelet count ≥ 80 × 10⁹\u002FL without blood transfusion within the past 14 days;\n  3. Hemoglobin \\> 8 g\u002FdL without blood transfusion or erythropoietin administration within the past 14 days;\n  4. Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN);\n  5. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (for subjects with liver metastasis, AST or ALT ≤ 5 × ULN is acceptable);\n  6. Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated by the Cockcroft-Gault formula) ≥ 60 mL\u002Fmin;\n  7. Adequate coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN;\n  8. Normal thyroid function, defined as Thyroid Stimulating Hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total triiodothyronine (T3) (or free triiodothyronine \\[FT3\\]) and free thyroxine (FT4) within the normal range are also eligible for enrollment;\n  9. Myocardial enzyme profile within the normal range;\n* Females of childbearing potential: negative pregnancy test (urine\u002Fserum) within 3 days pre-first dose (Cycle 1 Day 1); serum test required if urine test unconfirmed. Non-childbearing females: postmenopausal ≥ 1 year, surgically sterile or hysterectomized;\n* Subjects at risk of conception: use contraception with annual failure rate \\\u003C 1% during treatment and 120-180 days post-last dose;\n\nExclusion Criteria:\n\n* Lung metastases from other primary malignancies;\n* Other systemic malignancies (excluding radically treated skin basal\u002Fsquamous cell carcinoma or resected carcinoma in situ);\n* Current or prior myasthenia gravis;\n* Current or prior angle-closure glaucoma;\n* Current or prior benign prostatic hyperplasia;\n* Diphenhydramine allergy;\n* Pyloroduodenal obstruction, peptic ulcer-induced pyloric stenosis or bladder neck stenosis;\n* Prior radiation therapy meeting any: 1) ≥ 30% bone marrow irradiated within 14 days pre-treatment; 2) Lung lesion radiation \\> 30 Gy within 6 weeks pre-treatment (must recover from radiation toxicity to Grade ≤ 1, no glucocorticoids, no radiation pneumonitis history);\n* Current participation in other interventional clinical studies, or received investigational agents\u002Fdevices within 4 weeks pre-first dose;\n* Systemic anti-lung cancer Chinese patent medicines or immunomodulators (thymosin, interferon, interleukin; excluding local pleural effusion control) within 2 weeks pre-first dose;\n* Active autoimmune diseases requiring systemic therapy (disease-modifying drugs, glucocorticoids, immunosuppressants) within 2 years pre-first dose (replacement therapy not considered systemic);\n* Ongoing systemic glucocorticoids (excluding topical) or immunosuppressants within 7 days pre-first dose (physiological doses: prednisone ≤ 10 mg\u002Fday or equivalent permitted);\n* Uncontrolled pleural\u002Fperitoneal effusion (eligible if no drainage needed or effusion stable 3 days post-drainage cessation);\n* Prior allogeneic organ transplantation (except corneal) or hematopoietic stem cell transplantation;\n* Inadequate recovery from prior intervention toxicities\u002Fcomplications (not resolved to Grade ≤ 1 or baseline, excluding fatigue\u002Falopecia);\n* Known HIV infection (HIV 1\u002F2 antibody positive);\n* Other conditions deemed unsuitable by investigator;",{"count":515,"type":22},120,[25],"The goal of this clinical trial is to evaluate the efficacy and safety of H1 receptor antagonist (diphenhydramine) combined with toripalimab plus standard platinum-based chemotherapy in the perioperative setting in subjects with operable NSCLC.\n\nThe subjects of this study are patients with histologically or cytologically confirmed stage II-III NSCLC (AJCC Version 9) who are planned to receive neoadjuvant therapy with toripalimab combined with standard platinum-based chemotherapy. Eligible subjects were randomized at a 1:1 ratio to receive 3-4 cycles of neoadjuvant diphenhydramine (an H1 receptor antagonist) plus toripalimab and standard platinum-based chemotherapy, or toripalimab plus platinum-based chemotherapy alone, followed by treatment response evaluation and definitive surgery. After surgery, the experimental group will receive maintenance therapy with diphenhydramine (an H1 receptor antagonist) plus toripalimab for 13-14 cycles, while the control group will receive toripalimab monotherapy for the same 13-14 cycles.",[28],"2026-06-10",{"date":521,"type":33},"2026-06-12",{"date":71,"type":22},{"date":524,"type":22},"2029-01-01",{"name":526,"class":128},"Tianjin Medical University Cancer Institute and Hospital",{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":533,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":23,"phases":537,"briefSummary":538,"conditions":539,"keywords":554,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":577},"100520064","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-mesothelin-targeting-logic-gated-car-t-in-participants-with-solid-tumors-that-express-msln-and-have-lost-hla-a02-expression-100520064","NCT06051695","A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression","A Seamless Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Autologous Logic-gated Tmod™ CAR T Products, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression","EVEREST-2","Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\\*02 by NGS (whenever possible from the primary site), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy\n2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, OVCA, MESO, or other solid tumors with MSLN expression. Measurable disease is required with lesions of ≥1.0 cm by CT.\n3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol\n4. Has adequate organ function as described in the protocol\n5. ECOG performance status of 0 to 1\n6. Life expectancy of ≥3 months\n7. Willing to comply with study schedule of assessments including long term safety follow up\n\nKey Exclusion Criteria:\n\n1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative\n2. Prior allogeneic stem cell transplant\n3. Prior solid organ transplant\n4. MESO with pleural involvement extending into the peritoneum\n5. Cancer therapy within 3 weeks or 3 half lives of infusion\n6. Radiotherapy within 28 days of infusion\n7. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months\n8. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated\n9. History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year\n10. Requires supplemental home oxygen\n11. Females of childbearing potential who are pregnant or breastfeeding\n12. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion",{"count":536,"type":22},474,[52,25],"The goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\\*02 expression.\n\nThe main questions this study aims to answer are:\n\nPhase 1: What is the recommended dose that is safe for patients\n\nPhase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells\n\nParticipants will be required to perform study procedures and assessments, and will also receive the following study treatments:\n\nEnrollment and Apheresis in BASECAMP-1 (NCT04981119)\n\nPreconditioning Lymphodepletion (PCLD) Regimen\n\nTmod CAR T cells at the assigned dose",[540,149,28,327,541,542,543,544,545,146,546,547,548,60,549,550,551,552,202,553],"Solid Tumor, Adult","NSCLC, Recurrent","Non-Small Cell Squamous Lung Cancer","Pancreas Cancer","Pancreatic Neoplasm","Colorectal Adenocarcinoma","Colon Cancer","Rectal Cancer","Cancer","Ovarian Neoplasms","Mesothelioma","Mesothelioma, Malignant","Ovary Cancer","MESOM",[555,556,557,558,559,560,561,562,563,564,565,566,548,567,146,149,202,28,568,553,60,550,569],"CAR T Cell","Solid Tumors","Autologous","T Cell","Mesothelin","MSLN","HLA-A2","Solid Tumors expressing MSLN","Pancreatic","Cell Therapy","Gene Therapy","blocker","PANC","OVCA","Logic-gate",{"date":521,"type":33},{"date":572,"type":33},"2024-04-03",{"date":574,"type":22},"2029-06",{"name":576,"class":40},"A2 Biotherapeutics Inc.",12,{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":584,"targetDuration":4,"studyType":23,"phases":586,"briefSummary":587,"conditions":588,"keywords":589,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":129},"100642232","early-phase-1-a-prospective-multicenter-randomized-controlled-study-on-the-efficacy-and-safety-of-low-dose-carboplatin-combined-with-nab-paclitaxel-and-delayed-administration-of-serplulimab-as-first-line-treatment-for-advanced-squamous-non-small-cell-lung-cancer-100642232","NCT07647094","A Prospective, Multicenter, Randomized Controlled Study on the Efficacy and Safety of Low-dose Carboplatin Combined With Nab-Paclitaxel and Delayed Administration of Serplulimab as First-line Treatment for Advanced Squamous Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Sign a written informed consent before implementing any trial-related procedures;\n* Age ≥18 years and ≤75 years;\n* Histologically or cytologically confirmed locally advanced (IIIB-IIIC), metastatic, or recurrent (stage IV) squamous NSCLC (according to the 8th edition TNM lung cancer staging by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer), not suitable for surgery and radical concurrent chemoradiotherapy, and subjects who have not previously received systemic treatment;\n* Unknown gene status, or known histological specimen gene status confirming no EGFR gene-sensitive mutations or ALK gene fusion variations;\n* According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), at least one measurable lesion on imaging. Lesions in previously irradiated fields can be considered measurable if confirmed to have progressed;\n* No prior systemic anti-tumor treatment for advanced\u002Fmetastatic disease. Subjects who previously received platinum-containing adjuvant\u002Fneoadjuvant chemotherapy, or radical chemoradiotherapy for progressed disease, may be included if disease progression or recurrence occurs at least 6 months after the last chemotherapy drug treatment;\n* Subjects with asymptomatic or symptomatically stable brain metastases after local therapy are allowed to enroll if they meet the following conditions: measurable lesions outside the central nervous system; no central nervous system symptoms or no worsening symptoms within at least 2 weeks; no need for corticosteroid therapy, or corticosteroids discontinued within 7 days prior to first dose, or corticosteroid dose stable and reduced to ≤10 mg\u002Fday prednisone (or equivalent) within 7 days prior to first dose;\n* Patients may receive palliative radiotherapy, but completion must be at least 7 days before the first dose of the study drug, and radiotherapy-related toxicities must recover to ≤ grade 1 (CTCAE 5.0);\n* ECOG performance status 0-1;\n* Expected survival \\>3 months;\n* Sufficient organ function: subjects must meet the following laboratory criteria: Absolute neutrophil count (ANC) ≥1.5 x 10⁹\u002FL without using granulocyte colony-stimulating factor in the past 14 days; platelet count ≥100 × 10⁹\u002FL without transfusion in the past 14 days; hemoglobin \\>9 g\u002FdL without transfusion or erythropoietin use in the past 14 days; total bilirubin ≤1.5 times the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (for subjects with liver metastases, ALT or AST ≤5 × ULN is allowed); serum creatinine ≤1.5 × ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml\u002Fmin; good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN; normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects can still be included if total T3 (or FT3) and FT4 are within the normal range; myocardial enzyme spectrum within the normal range (subjects with isolated laboratory abnormalities deemed clinically insignificant by the investigator are also allowed to enroll).\n* For female subjects of childbearing potential, a urine or serum pregnancy test must be conducted within 3 days before the first study drug administration (Cycle 1, Day 1) and the result must be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing female subjects are defined as postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy.\n* If there is a risk of pregnancy, all subjects (male or female) must use contraception methods with an annual failure rate of less than 1% throughout the entire treatment period until 120 days (or 180 days) after the last study drug administration.\n\nExclusion Criteria:\n\n* Pathology is adenocarcinoma or small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC;\n* Received radiotherapy before the first study drug administration, meeting one of the following conditions: ≥30% of bone marrow received radiotherapy within 14 days before treatment; lung lesion radiotherapy with a dose \\>30Gy within 6 weeks before treatment (subjects must have recovered to grade 1 or below from previous radiotherapy toxicity, without the need for corticosteroid treatment, and no history of radiation pneumonitis); palliative radiotherapy completed within 7 days before the first study drug administration;\n* Diagnosed with other malignancies other than NSCLC within 5 years before the first administration (excluding completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For completely resected carcinoma in situ);\n* Currently participating in an interventional clinical study treatment or received other study drugs or investigational devices within 4 weeks before the first administration;\n* Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T cell receptor (e.g., CTLA-4, OX-40, CD137);\n* Received Chinese patent medicines or immunomodulatory drugs with anti-NSCLC indications (including thymosin, interferon, interleukin, excluding local use for pleural effusion control) for systemic treatment within 2 weeks before the first administration;\n* Experienced active autoimmune disease requiring systemic treatment (e.g., disease-relieving drugs, corticosteroids, or immunosuppressive agents) within 2 years before the first administration. Alternative therapies (e.g., thyroid hormones, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment;\n* Receiving systemic corticosteroid treatment (excluding nasal, inhaled, or other local corticosteroids) or any other form of immunosuppressive therapy within 7 days before the first study drug administration; Note: The use of physiological doses of corticosteroids (≤10 mg\u002Fday of prednisone or equivalent) is allowed.\n* Presence of clinically uncontrollable pleural effusion\u002Fascites (subjects who do not require drainage or whose effusion does not significantly increase after stopping drainage for 3 days may be enrolled);\n* Known history of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n* Known allergy to the study drugs Serplulimab, Nab-Paclitaxel, carboplatin, or any of their excipients;\n* Has not fully recovered from any toxicities and\u002For complications caused by prior interventions before starting treatment (i.e., ≤ Grade 1 or returned to baseline, excluding fatigue or alopecia);\n* Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive);\n* Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number above the detection limit); Note: Subjects with hepatitis B who meet the following criteria may also be enrolled: HBV viral load \\\u003C1000 copies\u002Fml (200 IU\u002Fml) before first dosing; subjects should receive anti-HBV treatment throughout the study chemotherapy to prevent viral reactivation; for subjects who are anti-HBc (), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is needed.\n* Subjects with active HCV infection (HCV antibody positive and HCV-RNA levels above the detection limit);\n* Received a live vaccine within 30 days before first dosing (Cycle 1, Day 1); Note: Receiving injectable inactivated vaccines for seasonal influenza within 30 days prior to first dosing is allowed; however, intranasal live attenuated influenza vaccines are not permitted.\n* Pregnant or breastfeeding women;\n* Presence of any serious or uncontrollable systemic disease, such as: significant and severe uncontrollable abnormalities in resting electrocardiogram in rhythm, conduction, or morphology, such as complete left bundle branch block, second degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation; unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) class ≥ 2; myocardial infarction within 6 months before enrollment; poorly controlled blood pressure (systolic \\>140 mmHg, diastolic \\>90 mmHg); history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before first administration, or current clinically active interstitial lung disease; active pulmonary tuberculosis; presence of active or uncontrolled infection requiring systemic treatment; clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction; liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; poorly controlled diabetes (fasting blood glucose (FBG) \\>10 mmol\u002FL); urinalysis showing proteinuria ≥ , and confirmed 24-hour urine protein quantification \\>1.0 g; presence of mental disorders making it impossible to comply with treatment;\n* History or evidence of disease, treatment or abnormal laboratory test values that may interfere with trial results or prevent the subject from participating in the study, or any other condition which the researcher considers unsuitable for enrollment, or other potential risks that the researcher believes make participation in this study inappropriate.",{"count":585,"type":22},112,[318],"This study is a multicenter randomized controlled clinical trial targeting subjects with advanced or metastatic squamous NSCLC with unknown or negative gene status, aiming to evaluate the efficacy and safety of first-line delayed administration of Serplulimab combined with a low-dose Nab-Paclitaxel doublet chemotherapy regimen.",[28],[590],"Non-small cell lung cancer","2026-06-09",{"date":500,"type":33},{"date":594,"type":33},"2025-11-01",{"date":596,"type":22},"2027-10-31",{"name":598,"class":128},"People's Hospital of Quzhou",{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":605,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":23,"phases":609,"briefSummary":610,"conditions":611,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":622,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":78},"100576736","phase-1-a-phase-1-first-in-human-study-of-okn4395-and-pembrolizumab-in-patients-with-solid-tumors-100576736","NCT06789172","A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors","A Phase 1, Open-label, Multicenter, Dose-escalation and Cohort Expansion Study of OKN4395, a Triple Antagonist of EP2, EP4, and DP1 Prostanoid Receptors, as Monotherapy and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors","INVOKE","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed disease, locally advanced or metastatic:\n\n   For Phase 1a:\n\n   Solid tumor with a COX2-associated immunosuppressive pathway, for which standard treatment options are not available, no longer effective, refused or not tolerated.\n\n   For Phase 1b:\n\n   For all cohorts, in the opinion of the investigator, all appropriate authorized treatment options should be exhausted\n   * Cohort 1: Sarcoma (fibrous sarcoma \\[myxofibrosarcoma or solitary fibrous tumor\\], dedifferentiated liposarcoma, undifferentiated pleomorphic sarcoma or pleomorphic sarcoma, or leiomyosarcoma), that is either refractory to or progressing on standard of care, with no more than 3 prior lines of systemic therapy. Patients with a solitary fibrous tumor can be included in the study without prior treatment if, in the investigator's opinion, it is in the participant's best interest and no established standard of care exists or is available.\n   * Cohort 2: NSCLC (squamous or adenomatous without EGFR\u002FALK mutations), with disease progression on a PD-(L)1 CPI regimen, and no more than 3 prior lines of systemic therapy. When known, PD-L1 status should be provided.\n   * Cohort 3: CRC (Microsatellite stable or Microsatellite instability - low), and no more than 4 prior lines of systemic therapy.\n   * Cohort 4: GC (gastric and gastro-esophageal junction adenocarcinoma), HER2-negative, planned to or currently receiving CPI monotherapy as maintenance of a first-line CPI + chemotherapy regimen, after chemotherapy cessation.\n2. ECOG performance status of 0 or 1.\n3. Recovery from any medically relevant AE\u002FirAE from previous treatment regimen (defined as recovery to Grade ≤1 level per CTCAE v 5.0 before Screening, or chronic, stable, Grade 2 AEs \\[not worsened to Grade \\>2 for \\>3 months prior to screening\\]).\n4. One or more new or growing tumor lesions amenable to a safe biopsy (at baseline, a suitable archival specimen obtained when not undergoing treatment and within 1 year \\[Phase 1a\\], or within 90 days and after the last administration of the previous systemic therapy \\[Phase 1b\\] is suitable). In addition (where applicable) an archival tumor biopsy collected before the start of the first-line treatment in the metastatic setting is requested (but optional).\n5. At least one target lesion measurable by RECIST 1.1 as noted by local investigators\u002Fradiologists.\n6. The ability to swallow and retain OKN4395 as an oral medication without significant gastrointestinal abnormalities that might alter absorption.\n7. The willingness and ability to comply with the evaluation, randomizations and requirements of the protocol. For Substudy 1, the ability to comply with the evaluation requirements includes the absence of any condition known to affect upper gastrointestinal motility, absorption, and pH.\n8. Adequate hematologic, renal, and hepatic function (based on local laboratory assessments):\n\n   1. Hematological variables: absolute neutrophil counts ≥1.5 × 109 \u002FL, platelet counts ≥75 × 109 \u002FL, and hemoglobin ≥8 g\u002FdL\n   2. Renal variables: creatinine clearance ≥ 60 mL\u002Fmin1 by Du Bois \\& Du Bois formula\n   3. Hepatic variables: total serum bilirubin ≤1.5 × ULN, AST and ALT ≤3 × ULN, and ALP ≤2.5 × ULN; except for hyperbilirubinemia of Gilbert's syndrome (participants with Gilbert's syndrome can be included if total serum bilirubin ≤5× ULN and direct bilirubin ≤1.5 x ULN)\n   4. Serum albumin ≥30 g\u002FL\n\nExclusion Criteria:\n\n1. Except for the current regimen in Cohort 4, ongoing or recent anticancer therapy within the following timeframe prior to first dose of study drug:\n\n   1. Chemotherapy, ADCs, or other antibodies \\\u003C 21 days\n   2. Immunotherapy or cellular therapy \\\u003C 28 days\n   3. Radiation therapy (palliative radiation for bone pain \\\u003C48 hours; stereotactic or small field brain irradiation \\\u003C7 days; all other radiation therapy \\\u003C14 days)\n   4. TKI or any other anticancer therapy \\\u003C 5 half-lives or \\\u003C 7 days, whichever is longer\n2. Central nervous system metastasis (radiologically progressive, or clinically symptomatic, or requiring immunosuppressive therapies \\[including low dose steroids\\]).\n3. Any active infection (bacterial, viral, fungal) requiring IV systemic therapy.\n4. Unstable COPD defined as frequent or severe exacerbations per investigator discretion.\n5. Known history of or active HBV (HBsAg reactive and\u002For HBV DNA detected) or HCV (HCV RNA detected) infection.\n6. HIV infection with CD4 lymphocyte count \\\u003C350 cells\u002FμL at time of Screening, or failure to achieve and maintain virologic suppression defined as confirmed HIV RNA level \\\u003C 50 or lower limit of detection by the local available assay at time of Screening and for at least 12 weeks prior to Screening.\n7. Known history of bleeding disorders, INR ≥1.5 × ULN at screening (or INR and\u002For aPTT within therapeutic range if on anticoagulation therapy), or a history of gastrointestinal bleeding (inflammatory, ulcerative, or diverticular) within the last 2 years.\n8. Known H. pylori infection without proof of eradication at least 2 months prior to screening.\n9. Systemic treatment with any drug known to impact gastrointestinal pH within 7 days (PPIs) or 12 hours (H2 antagonists) of first dose of OKN4395 (unless adapted after Substudy 1). Where said treatments have been used for more than 2 weeks prior to discontinuation, discontinuation should occur at least 21 days before first dose of OKN4395.\n10. Acute treatment with any systemic steroid therapy (\\>10 mg prednisone equivalent), or any corticosteroid medication within 14 days of first dose of OKN4395 for any condition.\n11. For participants planned to receive combination therapy: Ongoing and history of active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Any replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed. Participants with hyperthyroidism or hypothyroidism but that are stable on hormone replacement are also allowed.\n12. Systemic treatment with NSAIDs, COX2 inhibitors, or synthetic prostaglandins within 5 half-lives prior to the first dose of OKN4395 (acetylsalicylic acid ≤ 160 mg\u002Fday, or 325 mg ≤ 3 times\u002Fweek is permitted).\n13. Systemic treatment with strong inhibitors\u002Finducers of CYP and UGT enzymes within 14 days of first dose of OKN4395.\n14. QTcF interval of \\> 450 ms based on mean of the central triplicate readings.\n15. Known hypersensitivity to any excipients of the OKN4395 formulation or pembrolizumab (for combination cohorts).\n16. Pregnant or lactating women. Women of childbearing potential must have a negative serum pregnancy test at screening and have a negative a urine dipstick pregnancy test prior to the initiation of study treatment (can be done on C1-D1 visit).\n17. Evidence of any other active malignancy requiring systemic therapy within the 2 years prior to Screening. (Exceptions: non-melanoma skin cancer, in situ melanoma, in situ cervical cancer, ductal carcinoma in situ of the breast, or localized and presumed cured prostate cancer; participants on long-term anti-hormonal therapy for a prior malignancy are allowed if the malignancy has not been active within the prior 2 years).\n18. History or current evidence of any condition, surgical or medical therapy, or laboratory abnormalities that might confound the results of the study, make study drug administration hazardous, interfere with the participant's involvement for the full duration of the study, or make it difficult to monitor AEs such that, in the opinion of the treating physician, it is not in the best interest of the participant to participate",{"count":608,"type":22},146,[52],"The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab.\n\nThe overall objectives of this study are to determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OKN4395 alone and in combination with pembrolizumab, OKN4395 and metabolites (broken-down substances) of OKN4395 levels in the blood, and antitumor activity of OKN4395 alone and in combination with pembrolizumab.\n\nThis study will be split into 2 parts. Part 1a will look at multiple doses of OKN4395 either alone (monotherapy) or with pembrolizumab (combination therapy) administered on day 1 of each 21-day cycle in patients with solid tumors until the participant has disease progression or discontinues for any reason. The dose of OKN4395 will be increased, after each group of 3 or more participants completes their first 3 weeks of treatment and their data is evaluated for safety, with a planned dose range from 10 mg twice a day to 450 mg twice a day through 13 dose levels. Part 1a also includes a parallel substudy (Substudy 1) consisting of at least 12 participants, aiming to test the effect of food and stomach acid on the levels of OKN4395 in the blood as well as its tolerability.\n\nPart 1b will evaluate OKN4395 alone and in combination with pembrolizumab administered on day 1 of each 21-day cycle in patients with selected cancer types. Part 1b will comprise 4 cohorts: Cohort 1 in sarcoma (OKN4395 alone), Cohort 2 in non-small cell lung cancer (NSCLC), Cohort 3 in colorectal cancer, and Cohort 4 in gastric cancer (GC), with cohorts 2 to 4 in combination with pembrolizumab.\n\nThe overall study will enrol approximately 146 participants with up to 54 participants to receive OKN4395 alone and 12 participants to receive OKN4395 in combination with pembrolizumab in Part 1a, and 80 participants in Part 1b split: 20 on monotherapy and 60 on combination therapy.\n\nThe study will be conducted in the US, Australia, UK and in the EU.",[612,62,378,327,28,145,613,614,615,616,617,618,619,620,621],"Solid Tumours","Myxofibrosarcoma (MFS)","Solitary Fibrous Tumors","Dedifferentiated Liposarcoma","Undifferentiated Pleomorphic Sarcoma (UPS)","Leiomyosarcoma","Leiomyosarcoma (LMS)","Gastric Cancer (GC)","Gastric Cancer Adenocarcinoma Metastatic","Gastric \u002F Gastroesophageal Junction Adenocarcinoma",{"date":498,"type":33},{"date":624,"type":33},"2025-01-23",{"date":626,"type":22},"2028-09",{"name":628,"class":40},"Epkin",{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":636,"targetDuration":4,"studyType":23,"phases":638,"briefSummary":639,"conditions":640,"keywords":645,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":659,"startDateStruct":660,"completionDateStruct":662,"leadSponsor":664,"locationsCount":666},"100461030","phase-1-safety-and-tolerability-of-pb-dotam-grpr1-in-adult-subjects-with-recurrent-or-metastatic-grpr-expressing-tumors-100461030","NCT05283330","Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors","A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants With Recurrent or Metastatic GRPR-expressing Tumors","1. Adult participants (age ≥ 18 years old) with any of the following advanced or metastatic solid tumors (documented history of histologically confirmed diagnosis):\n\n   1. Metastatic castration-resistant prostate cancer (mCRPC) including neuroendocrine prostate cancer (NEPC) (enrolled only in SAD and MAD Q6W)\n   2. HR+\u002FHER2- breast cancer (estrogen receptor\u002FER expression \\>10% of tumor cell nuclei stain, regardless of progesterone receptor\u002FPgR expression); HER2-negative including HER2-low (as per relevant ASCO\u002FCAP guidelines)\n   3. Colorectal cancer\n   4. Cervical cancer\n   5. Non-small-cell lung cancer (NSCLC)\n   6. Recurrent glioblastoma (only enrolled in MAD Q4W cohorts) with evidence of recurrent disease (RD) demonstrated by disease progression using modified Response Assessment in Neuro-Oncology (RANO 2.0) criteria. Note: If surgery is performed for GBM recurrence, pre-surgery MRI will be used for confirmation of RD and residual and measurable disease post-surgery is not required but surgery must have confirmed the recurrence diagnosis by MRI.\n2. Capable of giving signed informed consent\n3. All participants must have progressed on at least 2 prior systemic therapies, except for recurrent GB\n4. For participants with mCRPC: Prior orchiectomy and\u002For ongoing androgen deprivation therapy and a castrate level of serum testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL)\n5. Presence of at least 1 measurable lesion per RECIST 1.1 as assessed by the Investigator (not applicable for GBM). At least 1 identified measurable lesion must show GRPR uptake in 203Pb-DOTAM-GRPR1 SPECT\u002FCT (uptake greater than that of the background) as assessed by the Investigator.\n6. For participants with prostate cancer that do not have measurable soft tissue disease, 203Pb-DOTAM-GRPR1 uptake in bone lesions \\> uptake in background is acceptable for eligibility.\n7. Eastern Cooperative Oncology Group (ECOG) status 0-1. Participants with ECOG status of 2 may be approved on a case-by-case basis in discussion with the Sponsor.\n8. Adequate bone marrow, hepatic, and renal function, as assessed by the following laboratory requirements:\n\n   1. White blood cell (WBC) ≥3000\u002F mm3 (≥ 3 x 109\u002FL)\n   2. Absolute neutrophil count (ANC) ≥1500\u002Fmm3 (≥1.5 x 109\u002FL)\n   3. Platelets ≥100,000\u002Fmm3 (≥ 100 x 109\u002FL)\n   4. Hemoglobin (Hb) ≥9.0 g\u002FdL\n   5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3x upper limit of normal (ULN) or ≤ 5 x ULN in the presence of liver metastases\n   6. Total bilirubin: ≤1.5 x ULN, except if documented history of Gilbert's disease who are eligible if total bilirubin ≤ 3 x ULN\n   7. Adequate renal function defined by creatinine clearance (CLCR) ≥ 60 mL\u002Fmin calculated as follows: CLCR = eGFR in ml\u002Fmin\u002F1.73 m2 calculated by the Modified Diet in Renal Disease (MDRD) x participant body surface area (BSA) in m2 ÷ 1.73\n   8. Serum amylase and\u002For lipase ≤1.5 x ULN\n9. For women of childbearing potential (WOCBP) and men with partners of childbearing potential: be willing to use highly effective methods of contraception or sexual abstinence, if part of participant's lifestyle, throughout the study and for 7 months for WOCBP, 4 months for men after the last \\[212Pb\\]Pb-DOTAM-GRPR1 administration or for 10 days following \\[203Pb\\]Pb-DOTAM-GRPR1 administration and participant is not proceeding to 212Pb-DOTAM-GRPR1 treatment, as outlined in protocol.\n\n   Participants with Recurrent Glioblastoma:\n10. Having first or second glioblastoma recurrence, after standard therapy that includes prior radiation therapy (RT) and at least 12 weeks from completion of RT prior to first administration of 212Pb-DOTAM-GRPR1. In case surgery has been performed for GBM recurrence, the surgery has to be completed at least 4 weeks prior to 212Pb-DOTAM-GRPR1 treatment start, with post-surgery recovery without any complications related to surgical procedure.\n11. Presence of 203Pb-DOTAM-GRPR1 uptake by SPECT\u002FCT scan in the tumor lesion(s).\n12. Presence of Gadolinium enhancement in the MRI in the tumor lesion(s) shown at the time of diagnosis of tumor recurrence.",{"count":637,"type":22},48,[52],"A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants with Recurrent or Metastatic GRPR-expressing Tumors",[641,233,546,28,642,643,644],"Cervical Cancer","mCRPC (Metastatic Castration-resistant Prostate Cancer)","Glioblastoma","Nonsmall Cell Lung Cancer",[230,646,647,648,649,650,198,149,641,651,652,653,654,655,656,657,658],"Advanced Cancer","Recurrent Cancer","Prostate Cancer, Castration-Resistant","Metastatic Prostate Cancer","Breast Cancer, Hormone Receptor Positive","Glioblastoma, Recurrent","Radioligand Therapy","Targeted Radiation Therapy","Gastrin-Releasing Peptide Receptor or Bombesin receptor subtype-2","Targeted Alpha Therapy","Lead-212 Radiopharmaceutical Therapy","Lead-203 Radiopharmaceutical Diagnostic","SPECT\u002FCT",{"date":498,"type":33},{"date":661,"type":33},"2022-12-22",{"date":663,"type":22},"2032-05",{"name":665,"class":40},"Orano Med Theranostics, SAS",8,{"id":668,"slug":669,"hasResults":12,"nctId":670,"briefTitle":671,"officialTitle":672,"acronym":4,"eligibilityCriteria":673,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":674,"targetDuration":4,"studyType":23,"phases":676,"briefSummary":677,"conditions":678,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":679,"lastUpdatePostDateStruct":680,"startDateStruct":681,"completionDateStruct":683,"leadSponsor":685,"locationsCount":129},"100642819","phase-2-efficacy-and-safety-of-induction-benmelstobart-plus-anlotinib-and-chemotherapy-followed-by-concurrent-chemoradiotherapy-and-benmelstobart-maintenance-versus-concurrent-chemoradiotherapy-followed-by-benmelstobart-maintenance-in-patients-with-unresectable-stage-iii-nsclc-100642819","NCT07643350","Efficacy and Safety of Induction Benmelstobart Plus Anlotinib and Chemotherapy Followed by Concurrent Chemoradiotherapy and Benmelstobart Maintenance Versus Concurrent Chemoradiotherapy Followed by Benmelstobart Maintenance in Patients With Unresectable Stage III NSCLC","Comparison of the Efficacy and Safety of Induction Benmelstobart Plus Anlotinib and Chemotherapy Followed by Concurrent Chemoradiotherapy and Benmelstobart Maintenance Versus Concurrent Chemoradiotherapy Followed by Benmelstobart Maintenance in Patients With Unresectable Stage III NSCLC: A Randomized, Controlled, Multicenter Phase II Clinical Study","Inclusion Criteria:\n\n* 1\\. Voluntary signing of a written ICF.\n* 2\\. Age at enrollment: 18-75 years; both sexes are eligible.\n* 3\\. Eastern Cooperative Oncology Group (ECOG) performance status score: 0 or 1.\n* 4\\. Expected survival: ≥3 months.\n* 5\\. Histologically or cytologically confirmed stage III NSCLC (classified according to the International Union Against Cancer and the American Joint Committee on Cancer's 9th edition of the lung cancer TNM staging system).\n* 6\\. Definitively determined as unresectable after MDT discussion.\n* 7\\. The primary driver genes must not harbor sensitive mutations (including EGFR (exon 19 deletion, exon 21 L858R point mutation, exon 20 insertion, etc.), ALK fusion, ROS1 fusion, MET exon 14 skipping mutation, HER2 exon 20 mutation, BRAF V600E mutation, RET fusion, NTRK fusion). For non-squamous NSCLC, a prior tissue-based common genetic testing report must be provided; otherwise, tumor tissue samples (archived or fresh, primary or metastatic) must be collected prior to enrollment for genetic mutation status assessment (at a local laboratory or central laboratory). For squamous NSCLC subjects with a smoking history or current smoking status, if the prior primary driver gene mutation status is unknown, no corresponding testing is required prior to enrollment, and the status shall be considered negative.\n* 8\\. No prior systemic antitumor therapy or chest radiotherapy for NSCLC.\n* 9\\. At least one measurable lesion according to RECIST v1.1, and such lesions must be suitable for repeated accurate measurement per RECIST v1.1 criteria. -10. Subjects must provide tumor tissue samples diagnosed as locally advanced tumors at the time of diagnosis or thereafter, including archived or freshly obtained uncolored formalin-fixed paraffin-embedded (FFPE) pathological sections (preferably recently obtained tumor tissue samples), approximately 10-25 sections (of which approximately 10-15 sections are required for EGFR and ALK testing, and approximately 10 sections for PD-L1 expression testing; however, additional sections must be provided if the central laboratory determines that the sample is insufficient for testing), or fresh tumor tissue specimens (frozen in liquid nitrogen for omics research). Tumor lesions used for fresh biopsy should not be designated as RECIST v1.1 target lesions unless the lesion is the only measurable lesion. For archived samples, collection must occur after the last systemic treatment, and the collection site must not have undergone radiotherapy. Note: If a subject's archived sample does not meet the above requirements, the investigator may determine that the biopsy does not serve the subject's best interests and may, after discussion with the project team, permit the use of the archived sample.\n* 11.Fertile female subjects must have undergone a urine or serum pregnancy test within 7 days prior to the first medication administration (if the urine pregnancy test result is not negative, a serum pregnancy test must be performed, with the serum result serving as the definitive determination), and the result must be negative. If a fertile female subject has sexual intercourse with an unmarried male partner, she must have used an acceptable contraceptive method since the start of screening and must agree to continue using contraception for 120 days after the last administration of the antitumor drug; whether contraception should be discontinued after this period should be discussed with the investigator.\n* 12\\. If an unmarried male subject has sexual intercourse with a fertile female partner, he must have used an effective contraceptive method from the start of screening until 120 days after the last administration; whether contraception should be discontinued after this time point should be discussed with the investigator.\n* 13\\. The subject must be willing and able to comply with all scheduled visits, treatment regimens, laboratory tests, and other study requirements.\n\nExclusion Criteria:\n\n* 1\\. Histopathological presence of any small cell carcinoma components, as well as specific types such as salivary gland type and SMARCA4 deletion.\n* 2\\. Except for NSCLC, the subject had suffered from other malignancies within the preceding 5 years. Subjects who have been cured of other tumors through local treatment (e.g., basal or squamous cell carcinoma of the skin, superficial bladder cancer, cervical or breast carcinoma in situ) are not excluded.\n* 3\\. Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up phase of an intervention study.\n* 4\\. Previous local treatments targeting the tumor lesion, such as thoracic radiotherapy or radiofrequency ablation.\n* 5\\. Receiving nonspecific immunomodulatory therapy (e.g., interleukins, interferons, thym peptides, tumor necrosis factor, etc., excluding IL-11 for thrombocytopenia) within 2 weeks prior to the first dose; or receiving herbal or proprietary Chinese medicines with antitumor indications within 1 week prior to the first dose.\n* 6\\. Suffering from an active autoimmune disease requiring systemic treatment within the past two years (e.g., treatment with disease-modifying drugs, corticosteroids, or immunosuppressants). Alternative therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic treatments.\n* 7\\. History of immunodeficiency; positive HIV antibody test; or current long-term use of systemic corticosteroids or other immunosuppressants.\n* 8\\. Subjects with known active tuberculosis (TB) or suspected active TB require clinical examination for exclusion; known active syphilis infection.\n* 9\\. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* 10\\. Non-infectious pneumonia\u002Finterstitial lung disease requiring systemic glucocorticoid therapy within the past 5 years or currently.\n* 11.Severe infections occurring within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infections treated with systemic anti-infective therapy within 2 weeks prior to the first dose (excluding antiviral therapy for hepatitis B or hepatitis C).\n* 12.Subjects with active Hepatitis B (Hepatitis B surface antigen \\[HBsAg\\] positive AND Hepatitis B virus DNA \\[HBVDNA\\] \\>1,000 copies\u002FmL \\[200IU\u002FmL\\] or above the lower limit of detection); note that HBsAg-positive subjects are required to receive antiviral therapy against Hepatitis B during the study treatment period. Subjects with active Hepatitis C (Hepatitis C virus \\[HCV\\] antibody positive AND HCV RNA levels above the lower limit of detection).\n* 13Has undergone major surgical procedures or sustained severe trauma within 30 days prior to the first dose administration, or plans to undergo major surgery within 30 days after the first dose (as determined by the investigator); has undergone minor local surgeries within 3 days prior to the first dose administration (excluding peripheral venous catheterization and intravenous infusion port implantation).\n* 14\\. The tumor invades or compresses surrounding vital organs (e.g., aorta, heart and pericardium, superior vena cava, trachea, esophagus) or carries a risk of esophageal-tracheal fistula or esophageal-plenic fistula; mediastinal lymph node metastasis involves the trachea or main bronchi with a risk of bronchial fistula.\n* 15\\. Currently has uncontrolled comorbid conditions, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or psychiatric\u002Fsocial conditions that may limit the subject's adherence to study requirements or affect their capacity to provide written informed consent.\n* 16\\. Has a history of myocarditis, cardiomyopathy, or malignant arrhythmias; experienced unstable angina, myocardial infarction, congestive heart failure, or vascular diseases (e.g., aneurysm with rupture risk) requiring hospitalization within 12 months prior to the first dose; or has other cardiac injuries that may affect the safety evaluation of antineoplastic agents.\n* 17\\. History of esophageal and gastric varices, severe ulcers, non-healed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose; or acute exacerbation of chronic obstructive pulmonary disease within 1 month prior to the first dose.\n* 18\\. History of any arterial thromboembolic event, venous thromboembolic event of grade 3 or higher per NCI CTCAE 5.0 criteria, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to the first dose; or current hypertension with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite oral antihypertensive therapy.\n* 19.Patients with a history of severe bleeding tendency or coagulation disorders; those with clinically significant hemoptysis (defined as coughing up or expectorating ≥ 1 teaspoon of fresh blood or small blood clots or only blood without sputum, patients with blood in sputum are allowed to be enrolled) within 1 month before the first administration; those with imaging findings during the screening period showing that the tumor encircles important blood vessels or has obvious necrosis or cavities, and the investigator determines that participation in the study would pose a risk of bleeding.\n* 20\\. Received a live vaccine within 30 days prior to the first dose, or plans to receive a live vaccine during the study period.\n* 21\\. Known hypersensitivity to any component of any antineoplastic agent; history of severe hypersensitivity reactions to other monoclonal antibodies.\n* 22\\. Known history of mental illness, drug abuse, alcoholism, or substance use.\n* 23\\. Women who are pregnant or breastfeeding.\n* 24\\. Any past or current medical conditions, treatments, or laboratory abnormalities that may confound study results, compromise the participant's ability to complete the study, or make participation potentially detrimental to the participant's best interests.\n* 25\\. Localized or systemic diseases not caused by malignancies, or tumor-related conditions or symptoms, that may pose significant medical risks and\u002For uncertainty in survival assessment, such as tumor-associated leukemic response (white blood cell count\\>20 × 10⁹\u002FL) or cachectic manifestations (e.g., known weight loss exceeding 10% within three months prior to screening).",{"count":675,"type":22},152,[25],"The goal of this clinical trial is to compare the efficacy and safety of induction Benmelstobart plus Anlotinib and chemotherapy followed by concurrent chemoradiotherapy (CCRT) and subsequent Benmelstobart maintenance versus CCRT followed by Benmelstobart maintenance in patients with unresectable stage III NSCLC. Additionally, high-throughput sequencing and multi-omics analysis will be performed on patient-derived tissue and blood samples. By integrating baseline characteristics with clinical data, we aim to identify key determinants of treatment efficacy and prognosis, thereby establishing a precision evaluation system for therapeutic outcomes.",[28],"2026-06-08",{"date":498,"type":33},{"date":682,"type":22},"2026-05-15",{"date":684,"type":22},"2031-05-15",{"name":686,"class":128},"The Third Xiangya Hospital of Central South University",{"id":688,"slug":689,"hasResults":12,"nctId":690,"briefTitle":691,"officialTitle":692,"acronym":4,"eligibilityCriteria":693,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":694,"targetDuration":4,"studyType":23,"phases":696,"briefSummary":697,"conditions":698,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":705,"lastUpdatePostDateStruct":706,"startDateStruct":707,"completionDateStruct":709,"leadSponsor":711,"locationsCount":713},"100483897","phase-1-a-study-to-evaluate-the-safety-pharmacokinetics-and-activity-of-enzelkitug-as-a-single-agent-and-in-combination-with-checkpoint-inhibitor-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100483897","NCT05581004","A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase Ia\u002FIb, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Life expectancy of at least 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)\n* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy\n* Tumor specimen availability\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of enzelkitug, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab\n* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and\u002For radiotherapy, within 3 weeks prior to initiation of study treatment\n* Active hepatitis B (HBV) or hepatitis C (HCV) or tuberculosis\n* Positive test for human immunodeficiency virus (HIV) infection\n* Acute or chronic active Epstein-Barr virus (EBV) infection at screening\n* Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first enzelkitug infusion\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* Active or history of autoimmune disease\n* Prior allogeneic stem cell or organ transplantation",{"count":695,"type":22},450,[52],"This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.",[699,28,378,375,243,700,701,641,149,702,703,704],"Locally Advanced or Metastatic Solid Tumors","Esophageal Cancer","Gastric Cancer","Urothelial Carcinoma","Clear Cell RCC","HCC","2026-06-05",{"date":591,"type":33},{"date":708,"type":33},"2022-10-20",{"date":710,"type":22},"2028-07-31",{"name":712,"class":40},"Genentech, Inc.",41,{"id":715,"slug":716,"hasResults":12,"nctId":717,"briefTitle":718,"officialTitle":718,"acronym":4,"eligibilityCriteria":719,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":720,"targetDuration":4,"studyType":722,"phases":4,"briefSummary":723,"conditions":724,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":726,"lastUpdatePostDateStruct":727,"startDateStruct":728,"completionDateStruct":730,"leadSponsor":732,"locationsCount":129},"100643235","immune-metabolism-dysregulation-and-efficacy-to-anti-pd-1-pd-l1-agents-in-non-small-cell-lung-cancer-patients-100643235","NCT07637474","Immune Metabolism Dysregulation and Efficacy to Anti-PD-1 PD-L1 Agents in Non Small Cell Lung Cancer Patients","Inclusion Criteria:\n\n* Age \\> 18 years\n* Histological diagnosis of advanced stage NSCLC\n* Histotype adenocarcinoma and squamous carcinoma\n* ECOG PS \\\u003C2\n* Known PDL-1 stage\n* Measurable disease\n* Availability of tumor tissue\n* No evidence of molecular drivers\n* Written informed consent (to the study and data processing)\n\nFor the second cohort in addition to the precedents it is included\n\n* Diagnosis of limited or locally advanced NSCLC deemed resectable\n\nFor the third cohort in addition to the precedents it is included\n\n* patients candidates for surgery for non-small cell lung cancer\n\nExclusion Criteria:\n\n* Contraindications to immunotherapy\n* Unavailability of tumor tissue\n* Histotype with neuroendocrine or mixed component\n\nFor the second cohort\n\n* Contraindication to immunotherapy\n* Histotype with neuroendocrine or mixed component\n* Locally advanced disease candidate for concomitant chemo-radiotherapy treatment\n\nFor the third cohort\n\n* previously treated patients",{"count":721,"type":22},150,"OBSERVATIONAL","Prospective, biological, observational study involving the collection and use of samples from patients suffering from NSCLC lung cancer, aimed at comparing the molecular profile related to metabolism among subjects with response or resistance to checkpoint inhibitors immune system (ICI), in order to contribute to define response biomarkers and new molecular pathways as therapeutic targets combine with ICI to overcome resistance.",[725],"Nsclc","2026-06-04",{"date":591,"type":33},{"date":729,"type":33},"2024-07-24",{"date":731,"type":22},"2026-07-24",{"name":733,"class":128},"Regina Elena Cancer Institute",{"id":735,"slug":736,"hasResults":12,"nctId":737,"briefTitle":738,"officialTitle":739,"acronym":4,"eligibilityCriteria":740,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":741,"targetDuration":4,"studyType":23,"phases":743,"briefSummary":744,"conditions":745,"keywords":754,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":769,"lastUpdatePostDateStruct":770,"startDateStruct":772,"completionDateStruct":774,"leadSponsor":776,"locationsCount":778},"100586569","phase-1-bbo-11818-in-adult-subjects-with-kras-mutant-cancer-100586569","NCT06917079","BBO-11818 in Adult Subjects With KRAS Mutant Cancer","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers","Inclusion Criteria:\n\n* Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation\n* Measurable disease by RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Life expectancy \\>24 weeks\n* Adequate organ function\n\nExclusion Criteria:\n\n* Malignancy within the last 2 years as specified in the protocol\n* Untreated brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol.",{"count":742,"type":22},665,[52],"A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.",[198,28,746,747,748,749,428,750,417,751,418,752,753,540],"PDAC - Pancreatic Ductal Adenocarcinoma","CRC (Colorectal Cancer)","Metastatic Non-Small Lung Cell Cancer","Metastatic Colorectal Cancer (CRC)","KRAS G12C","KRAS G12S","Metastatic Pancreatic Ductal Adenocarcinoma","Advanced Lung Carcinoma",[755,756,757,758,28,146,759,230,646,760,761,762,763,764,765,766,767,768,497],"BBOT","BridgeBio Oncology Therapeutics","Phase1","Phase 1a\u002F1b","PDAC","Pembrolizumab","Cetuximab","Platinum Chemotherapy","Pemetrexed","KONQUER","KONQUER-101","mFOLFOX6","mFOLFIRINOX","Gemcitabine","2026-05-29",{"date":771,"type":33},"2026-06-02",{"date":773,"type":33},"2025-03-31",{"date":775,"type":22},"2029-09",{"name":777,"class":40},"TheRas, Inc., d\u002Fb\u002Fa BBOT (BridgeBio Oncology Therapeutics)",17,{"id":780,"slug":781,"hasResults":12,"nctId":782,"briefTitle":783,"officialTitle":784,"acronym":4,"eligibilityCriteria":785,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":786,"targetDuration":4,"studyType":23,"phases":787,"briefSummary":788,"conditions":789,"keywords":792,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":769,"lastUpdatePostDateStruct":794,"startDateStruct":795,"completionDateStruct":797,"leadSponsor":799,"locationsCount":41},"100572295","phase-2-reduced-ct--anti-pd-1-as-first-line-tx-in-vulnerable-older-adults-wadv-50-pd-l1-non-small-cell-lung-cancer-nsclc-100572295","NCT06731413","Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w\u002FAdv \u003C50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)","Phase 2 Study to Evaluate Reduced Dose Chemotherapy in Combination With Anti-PD-1 Therapy as First Line Treatment in Vulnerable or Older Adults (Vulnerable or Age ≥70) With Advanced PD-L1 TPS \u003C50% Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (either squamous or non- squamous)\n* Stage IIIB, IIIC or IV disease OR have recurrent disease and not be candidates for curative treatment such as combined chemo-radiation\n* No previous line of treatment in the recurrent or metastatic setting. Neoadjuvant or adjuvant treatment more than 6 months before enrollment is acceptable.\n* Age 70 or meeting frailty definition or above at the date of signing informed consent\n* Absence of driver mutations that have first line Food and Drug Administration (FDA) approved targeted therapy (biomarker testing is optional for squamous cell)\n* PD-L1 tumor proportion score (TPS) of less than 50%\n* Eastern Cooperative Oncology Group (ECOG) PS of 0-3\n* Have measurable disease based on RECIST 1.1 as determined by the local site investigator\u002Fradiology assessment\n* Absolute neutrophil count (ANC) ≥ 1,000\u002FμL\n* Platelets ≥ 75,000\u002FμL\n* Hemoglobin (Hgb) ≥ 8.0 g\u002FdL (transfusion permitted)\n* Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)\n* Aspartate amino transferase (AST)serum glutamic-oxaloacetic transaminase (SGOT) \u002Falanine aminotransferase (ALT)serum glutamic-pyruvic transaminase (SGPT) ≤ 5.0 × institutional ULN\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Participants with life expectancy of less than 3 months at the time of enrollment\n* Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, or immunosuppressive drugs)\n* Diagnosis of interstitial lung disease\n* Creatinine clearance of \\\u003C30 mL\u002Fmin\n* Symptomatic, untreated central nervous system (CNS) disease or leptomeningeal disease. Patients with asymptomatic or treated CNS disease are eligible\n* Required ongoing use of immunosuppressive medication, including steroids, with the following allowable exceptions:\n\n  * Doses less than or equal to the equivalent of prednisone 10 mg daily\n  * Short courses of steroids that are discontinued prior to enrollment\n  * Inhaled, intranasal and\u002For topical steroids\n  * Dexamethasone taper for treating vasogenic edema associated with CNS disease",{"count":115,"type":22},[25],"Evaluate frequency of adverse events that lead to chemotherapy discontinuation in vulnerable older adults with recurrent\u002Fmetastatic PD-L1 TPS\\\u003C50% NSCLC patients who receive reduced dose chemotherapy in combination with immunotherapy.",[198,28,790,791],"Advanced Non-Small Cell Lung Cancer","Metastatic Non Small Cell Lung Cancer",[793],"Non-Small Cell Lung Cancer, NSCLC",{"date":771,"type":33},{"date":796,"type":33},"2025-02-11",{"date":798,"type":22},"2033-07-30",{"name":800,"class":128},"Virginia Commonwealth University"]